BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2120871 · Received June 11, 2011

    Report

    Report Number
    6000001-2011-07540
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-12/1/08-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH DAMAGED BATTERY WAS CONFIRMED AND REPRODUCED DURING PRODUCT EVALUATION. THE ASSIGNABLE CAUSE FOR THE REPORTED PROBLEM WAS DETERMINED TO BE DEPLETED BATTERIES RESULTING FROM USER ERROR. THE MAIN BATTERIES WERE REPLACED TO CORRECT THE REPORTED CONDITION. ADDITIONAL INFORMATION: THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. A LABELING REVIEW WAS PERFORMED AND IT WAS FOUND UPON REVIEW OF THE OPERATOR'S MANUAL, SUFFICIENT INSTRUCTIONS EXIST FOR THE USER TO FOLLOW TO PREVENT THIS PROBLEM. FROM THE EVENT HISTORY LOG IT WAS IDENTIFIED THAT THE PUMP WAS NOT CHARGED FOR 12 HOURS AFTER BATTERY LOW/BATTERY DEPLETED SET OCCURRED WHICH GOES AGAINST THE INSTRUCTIONS GIVEN IN THE MANUAL INDICATING A USER ERROR. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL DATE RECEIVED BY MANUFACTURER WAS REPORTED INCORRECTLY; IT SHOULD HAVE BEEN 06/01/2011.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE CONTACTED A TECHNICAL SERVICE REPRESENTATIVE TO REPORT A COLLEAGUE INFUSION PUMP WITH THE REPORTED CONDITION "DAMAGED BATTERY." THIS CONDITION HAD THE POTENTIAL TO CAUSE AN INTERRUPTION OF DELIVERY. THIS EVENT OCCURRED DURING POWER UP. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO KNOWN PATIENT INVOLVEMENT AND NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1