BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP

    MDR report key: 1832738 · Received September 13, 2010

    Report

    Report Number
    6000001-2007-01073
    Event Type
    Malfunction
    Date Received
    September 13, 2010
    Date of Event
    November 1, 2006
    Report Date
    November 30, 2006
    Manufacturer
    BAXTER HEALTHCARE PTE. LTD.
    Product Code
    FRN
    Removal / Correction Number
    CONTINUED ON H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA ON (B)(4) 2007. EVALUATION SUMMARY: THE DEVICE WAS EVALUATED AT A BAXTER SERVICE CENTER. THE REPORTED CONDITION OF DEFECTIVE BATTERY WAS CONFIRMED. FAILURE CODE 570 WAS FOUND TO HAVE OCCURRED IN THE EVENT HISTORY AND THE BATTERIES WERE FOUND DEPLETED TO A POTENTIALLY DAMAGING LEVEL WITH 13 DISCHARGES BELOW ALARM THRESHOLD. THE BATTERIES WERE REPLACED AND THE DEVICE WAS RETURNED TO THE CUSTOMER FULLY OPERATIONAL. REVIEW OF THE COMPLAINT HISTORY REVEALS SIMILAR REPORTS HAVE BEEN RECEIVED FOR THIS PRODUCT FOR THE REPORTED ISSUE. THIS ISSUE IS BEING INVESTIGATED UNDER CAPA, MDQ-CAPA-132. 6000001-2/25/05-004-C, 6000001-12/13/05-019-C.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FAILURE OF DEFECTIVE BATTERY. CUSTOMER REPORTED THERE WERE NO PATIENT INJURIES OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. CUSTOMER DID NOT HAVE INFORMATION WHETHER INCIDENT OCCURRED DURING PATIENT INFUSION. ALTHOUGH BAXTER REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING PATIENT DEMOGRAPHICS, MEDICATION INVOLVED, OR DEVICE PROGRAMMING INFORMATION. NO ADDITIONAL CONTACT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1