BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2141857 · Received June 27, 2011

    Report

    Report Number
    6000001-2011-09015
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH MDQ (B)(4). SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A MALFUNCTION OF BATTERY ISSUE WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION AS A DAMAGED BATTERY ALARM. THIS CONDITION WAS CAUSED BY DEPLETED AND FAULTY MAIN BATTERIES. THE MAIN BATTERIES AND BATTERY HARNESS WERE REPLACED TO CORRECT THIS CONDITION. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED A BATTERY ISSUE. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS INVOLVED A COLLEAGUE P1.5 INFUSION PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 6.13.92.

    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