BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 1943224 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06524
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP THAT EXPERIENCED AN AIR IN LINE ALARM WAS CONFIRMED BUT COULD NOT BE REPRODUCED. NO ROOT CAUSE COULD BE IDENTIFIED. THIS DEVICE DID NOT MEET SPECIFICATION FOR THE REPORTED CONDITION; THEREFORE THE PUMPHEAD MODULE WAS REPLACED AT THE FACILITY BY A BAXTER FIELD SERVICE TECHNICIAN. 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 AN AIR IN LINE ALARM. THIS EVENT MAY HAVE BEEN A FALSE ALARM. IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE EVENT IN ASSOCIATION WITH THIS CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.08.92.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1