baxter - sfda

Baxter(MOH letter)

January 13th, 2015

At the kind attention of: National Center For Medical Device reportingMedical Devices Sector - SFDAKingdom of Saudi ArabiaTel.: (+966) (1) 2759222Fax: (+966)(1)2757245E-mail: [email protected]

Subject: Important Product Information - Colleague - Increase in MTR Use Errorcomplaints

Product Codes: vP1.7 COLLEAGUE Pump. (2M91617 and 2M91637)

Serial numbers: All

Dear NCMDR Team,

Baxter Healthcare Corporation is issuing this communication for the COLLEAGUE Pump toremind users to reset the Manual Tube Release (MTR) when it is left in the open position.Users that do not follow the labeled instructions for resetting the MTR prior to use will beunable to power on the device.

This has the potential to lead to a delay in therapy as the device will not power on. A delay intherapy has the potential to cause harm when life supporting therapies are intended to beadministered. Baxter has received complaints for this issue; however, no adverse eventshave been reported.

Customers are reminded to follow the instructions for resetting the MTR prior to use.Instructions are located on the pump head module next to the MTR knob (figure 1) and in theoperator's manual in section 11-17.

(OPEN Manual Tube Release

e0~o P...h 0 Tum &OPEN

MUST RESET to use pump

'~~e,OPu.h OTurn ORESET.

j

Figure 1

FCA-2014-037

Baxter AGMullerenstrasse 3, VolketswilPostfach CH·8604, Switzerland

of 2

Baxter AG Scientific OfficePO Box 64332, Dubai, UAETel +971.4.4298100

Baxter

Our records indicate that 01 customer (our distributor Arabian Healthcare Supply Co.) hasreceived this product in Saudi Arabia. For your information, please find attached thecommunication that is being sent to the customers.

Should you have any questions, please contact Ziad Awadallah at +966 11 4343714

Sincerely,

ZIAD AWADALLAHCQA Officer KSABaxter AG.P.O. Box 246968 Riyadh 11312 Saudi ArabiaPhone: +966 11 4343 714Fax +966 11 4343 777E-mail [email protected]

Attachment 1: Customer Letter

FCA-2014-037

Baxter AGMjjllerenstrasse 3, VolketswilPostfach CH-8604, Switzerland

--~.

"'-.

of 2

Baxter AG Scientific OfficePO Box 64332, Dubai, UAETel +971.4.4298100

BaxterCustomer letter

Attachment 1: Customer Letter

I IMPORTANT PRODUCT INFORMATION I

January xx, 2015 (to be adapted locally)

Subject: Important Product Information - Colleague -Increase in MTR Use Error complaints

Product codes: vP1.7 COLLEAGUE Pump. Please see Attachment 1 for a listing of all product codes

(to be adapted locally).

Serial numbers: All

Dear Healthcare Professional/Purchasers/Biomedical EngineerslUsers, (to be adapted locally)

Baxter Healthcare Corporation is issuing this communication for the COLLEAGUE Pump to remind users toreset the Manual Tube Release (MTR) when it is left in the open position. Users that do not follow thelabeled instructions for resetting the MTR prior to use will be unable to power on the device.

HazardInvolved

Action to betaken bycustomers

This has the potential to lead to a delay in therapy as the device will not poweron. A delay in therapy has the potential to cause harm when life supportingtherapies are intended to be administered. Baxter has received complaints forthis issue; however, no adverse events have been reported.

Customers are reminded to follow the instructions for resetting the MTR prior touse. Instructions are located on the pump head module next to the MTR knob(figure 1) and in the operator's manual in section 11-17.(to be adaptedlocally)

- ~ - ......OPEN Manual Tube Rel••se "

~0~o Pu." e Tum OOPEN

MUST RESET to use pump

~$~o Push 0 Turn 0 RESET

Figure 1

FCA·2014·037 Baxter and COLLEAGUE are registered trademarks of Baxter International, Inc. Page 1 of 5


Action to betaken inresponse tothis notification

Furtherinformation andsupport

Baxter is kindly requesting that you take the following actions in response tothis notification:

1. Acknowledge your receipt of this Important Product Information bycompleting the attached Customer Reply Form (Attachment 2) andreturn it to Baxter by either faxing it to XX (to be adapted locally) orscanning and e-mailing it to (to be adapted locally). Returning theCustomer Reply Form promptly will prevent you from receiving repeatnotifications.

2. If you distribute this product to other facilities or departments within yourinstitution, please forward a copy of this letter to them to ensure thatthey are aware of this communication. (to be adapted locally)

3. If you are a dealer, wholesaler, or distributor/reseller that distributed anyproduct to other facilities, please notify your customers of this action.(to be adapted locally)

If you have questions regarding this communication, please call... (to beadapted locally)

The local MOH (to be adapted locally) has been notified of this action. (to be adapted/removed locally)

Sincerely,

Name (to be adapted locally)Title (to be adapted locally)Medical Products (to be adapted locally)Baxter Healthcare (to be adapted locally)

Attachment 1: vP1.7 COLLEAGUE Pump. Product Code ListingAttachment 2: Customer Reply Form

FCA-2014-037 Baxter and COLLEAGUE are registered trademarks of Baxter International, Inc. Page 2 of 5


ATTACHMENT 1Important Product Information

vP1.7 COLLEAGUE Pump Product Code Listing(to be adapted locally)

Product Code# Product Name Affected Serial Numbers

2M81517K Colleague Single Channel Mono Chrome PumpEnglish v1.7

2M81537K Colleague Triple Channel Mono Chrome PumpEnglish v1.7

CNM81517 Colleague Single Channel Mono Chrome Pump,Swedish v1. 7

CNM81537 Colleague Triple Channel Mono Chrome Pump,Swedish v1. 7

DNM81517 Colleague Single Channel Mono Chrome PumpFrench v1.7

DNM81537 Colleague Triple Channel Mono Chrome PumpFrench v1.7

GNM81517 Colleague Single Channel Mono Chrome Pump,DAN/NOR v1.7

GNM81537 Colleague Triple Channel Mono Chrome Pump, All[;JAN/NOR v1.7

HNM81517 Colleague Single Channel Mono Chrome Pump,German v1.7

HNM81537 Colleague Triple Channel Mono Chrome Pump,German v1.7

PNM81517 Colleague Single Channel Mono Chrome Pump,Spanish v1. 7

PNM81537 Colleague Triple Channel Mono Chrome Pump,Spanish v1. 7

WNM81517 Colleague Single Channel Mono Chrome Pump,Dutch v1.7

WNM81537 Colleague Triple Channel Mono Chrome Pump,Dutch v1.7

2M81517 Colleague Single Channel Mono Chrome Pump v1.7



2M81537 Colleague Triple Channel Mono Chrome Pump v1. 7

2M91617 Colleague Single Channel CXE Pump v1.7

2M91617A Colleague Single Channel CXE Pump v1.7

2M91637 Colleague Triple Channel CXE Pump v1. 7

2M91637A Colleague Triple Channel CXE Pump v1. 7

DNM91617 Colleague Single Channel CXE Pump, French v1.7

DNM91637 Colleague Triple Channel CXE Pump, French v1. 7

DNM91617A Colleague Single Channel CXE Pump, French v1.7

DNM91637A Colleague Triple Channel CXE Pump, French v1. 7

PNM91617 Colleague Single Channel CXE Pump, Spanish v1.7

PNM91637 Colleague Triple Channel CXE Pump, Spanish v1.7



Attachment 2CUSTOMER REPL Y FORM

(IMPORTANT PRODUCT INFORMA TlON LETTER DATEDXXXXXX (TO BE COMPLETED LOCALL Y)

vP1.7 COLLEAGUE PUMPProduct code: (to be completed locally)

Serial Number: All

Please complete and return one copy of this form per facility either by fax (Fax: ) or by e-mail ( ) as confirmation that you have received this notification.

A fax cover sheet is not required.(Can be adapted locally)

Facility Name and Address:

(Please Print!Reply Contirmation Completed By:(Please Print Name)

Title:

(Please Printl

Email andlor Telephone Number (IncludingArea Code):

o We have received the above mentioned letter and have disseminated this information to our staff,

other services and facilities.

o We have received the above mentioned letter and have disseminated this information to customers.

ISignature/Date:REQUIRED FIELD


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