BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE

    MDR report key: 2222220 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20567
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    June 20, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION. HOWEVER, THE CUSTOMER HAS INSPECTED AND REPAIRED THE DEVICE THEMSELVES ON-SITE. UPON FURTHER REVIEW, QUALITY ENGINEERING HAS CONFIRMED THE REPORTED CONDITION. THE ROOT CAUSE WAS ASSIGNED TO A FUSE ISSUE. THE CUSTOMER REPAIRED THE MAIN INLET FUSES TO CORRECT THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS DISTRIBUTED OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE, IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE FACILITY REPLACED THE MAIN INLET FUSE TO CORRECT THE REPORTED CONDITION AND HAS PUT THE DEVICE BACK INTO SERVICE. THEREFORE, THE DEVICE WILL NOT BE SENT TO BAXTER FOR EVALUATION OR REPAIR. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS A P1.7 COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 7.01.00. A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE. CORRECTION: INFORMATION ERRONEOUSLY OMITTED FROM INITIAL MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A FAULTY MAIN INLET FUSE ISSUE. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS UNKNOWN. THIS IS A CASE, WHICH WAS REPORTED TO BAXTER (B)(4) TS ON 10 AUGUST 2011. THE COMPLAINT WAS RECEIVED FROM (B)(4) HOSPITAL AND REFERS TO AN INCIDENT INVOLVING COLLEAGUE SINGLE CHANNEL MONOCHROME PUMP ENGLISH V1.7 ((B)(4) ON SERIAL NUMBER (B)(4). THE REPORTER STATES CUSTOMER HAS REPORTED THAT P1.7 DEVICE/SN, HAS NO MAINS LED LIT WHEN PLUGGED INTO MAINS SUPPLY. MAINS INLET FUSES HAVE BEEN FOUND TO BE FAULTY AND HAVE BEEN REPLACED BY THE CUSTOMER AND PUT DEVICE BACK INTO SERVICE. THIS HAS BEEN LOGGED FOR TRENDING PURPOSES ONLY. THE EVENT DATE IS CORRECT. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1