BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE VOLUMETRIC INFUSION PUP

    MDR report key: 760826 · Received October 19, 2005

    Report

    Report Number
    6000001-2005-05340
    Event Type
    Malfunction
    Date Received
    October 19, 2005
    Date of Event
    September 1, 2005
    Report Date
    September 22, 2005
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    6000001-2/25/05-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. SHOULD THE PUMP BE RECEIVED FOR EVALUATION, A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFO BECOMES AVAILABLE. THE FAILURE CODE 570 INDICATES THAT THE BATTERY DISCHARGED TO A POTENTIALLY DAMAGING LEVEL. CAPA MDQ-CAPA-132 WAS OPENED AND IS INVESTIGATING REPORTS OF THE FAILURE CODE 570.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAILURE CODE 570:20. CUSTOMER REPORTED THERE WERE NO PT INJURIES ASSOCIATED WITH THIS REPORT AND THERE HAVE BEEN NO INCIDENT REPORTS FILED SINCE THE LAST BAXTER SERVICE EVENT. CUSTOMER DID NOT HAVE INFO WHETHER INCIDENT OCCURRED DURING PT INFUSION. ALTHOUGH BAXTER REQUESTED, NO ADDITIONAL INFO WAS PROVIDED REGARDING PT DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING INFO. NO ADDITIONAL CONTACT INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN