BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSOR PUMP-SINGLE CHANNEL

    MDR report key: 1952984 · Received January 7, 2011

    Report

    Report Number
    6000001-2011-00115
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL INFORMATION: 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). EVALUATION SUMMARY: THE REPORTED CONDITION OF A COLLEAGUE INFUSION PUMP WITH A FALSE AIR IN LINE ALARM WAS CONFIRMED BUT NOT DUPLICATED DURING PRODUCT EVALUATION. ACCURACY TESTS WERE PERFORMED AND FOUND THE PUMP TO BE WITHIN SPECIFICATIONS. THEREFORE, NO ASSIGNABLE CAUSE COULD BE PROVIDED FOR THE REPORTED CONDITION AND NO REPAIR WAS NECESSARY. UPON FURTHER REVIEW OF THE EVENT HISTORY, THE OCCURRENCE DATE OF THIS EVENT WAS DETERMINED TO BE (B)(4) 2010. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS PREVIOUSLY SERVICED FOR THE REPORTED CONDITION. DURING PREVIOUS SERVICE, THE AIR IN LINE PRINTED CIRCUIT BOARD WAS CALIBRATED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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 MDQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE FACILITY REPORTED A COLLEAGUE INFUSION PUMP WITH A FALSE AIR IN LINE ALARM. ACCORDING TO THE FACILITY, THIS EVENT OCCURRED DURING PATIENT USE AT THE START OF INFUSION IN THE EMERGENCY ROOM DEPARTMENT. THE PUMP WAS SWAPPED OUT FOR ANOTHER AND THE PATIENT'S THERAPY CONTINUED WITHOUT FURTHER PROBLEMS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS PUMP IS CURRENTLY UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1