BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1172672 · Received September 19, 2008

    Report

    Report Number
    6000001-2008-00550
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED CONDITION OF DAMAGED PUMP HEAD MODULE KEYPAD WAS CONFIRMING DURING PRODUCT EVALUATION. INSPECTION OF THIS PUMP REVEALED THE CONDITION WAS CAUSED BY PHYSICAL DAMAGE. TO CORRECT THIS CONDITION, THE PUMP HEAD MODULE KEYPAD WAS REPLACED. THE PUMP WAS RETESTED AND RETURNED TO THE CUSTOMER WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTED A DEVICE WITH A DAMAGED PUMP HEAD MODULE KEYPAD. THIS CONDITION OCCURRED DURING BIO-MED TESTING. THERE WAS NO PATIENT OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REP. NO ADDITIONAL INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP 80FRN FRN BAXTER HEALTHCARE PTE. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1