BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2211194 · Received August 15, 2011

    Report

    Report Number
    6000001-2011-18864
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW REVEALED THAT THE DEVICE HAS BEEN SERVICED FOUR TIMES PRIOR TO THIS EVENT. THE DEVICE HAS BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF "DAMAGED BATTERY." PREVIOUS SERVICE ON 04/10/2009 WAS FOR "DAMAGED BATTERY." THE BATTERIES AND THE BATTERY HARNESS WAS REPLACED. ALSO DURING PREVIOUS SERVICE ON 7/24/2008, 10/11/2010, THE BATTERIES AND BATTERY HARNESS WERE REPLACED. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE. THE DEVICE WAS NEVER RETURNED BY THE CUSTOMER, THEREFORE NO EVALUATION WILL BE MADE IN REGARDS TO THE REPORTED CONDITION.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WITH A DAMAGED BATTERY FOUND UPON POWER UP OF THE DEVICE. IT IS UNKNOWN IN WHICH CARE AREA THIS EVENT OCCURRED. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE FACILITY REPRESENTATIVE STATED THAT THERE WAS NO INFORMATION REGARDING PATIENT INVOLVEMENT, HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION IS UNKNOWN AT THIS TIME.

    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