BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE SINGLE CHANNEL VOLUMETRIC PUMP CE FRENCH

    MDR report key: 2071939 · Received April 28, 2011

    Report

    Report Number
    6000001-2011-03251
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Removal / Correction Number
    6000001-12/1/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    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. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGNABLE CAUSE WAS DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS HAVE BEEN REPLACED. ADDITIONAL: THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION (B)(4).

    Description of Event or Problem · 1

    BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE INFUSION PUMP FOR A DAMAGED BATTERY. THE PROCESS STEP WAS UNKNOWN AND ANY REPORT OF PATIENT INVOLVEMENT IS UNKNOWN. THERE IS NO PATIENT INJURY REPORTED. THE BAXTER FIELD SERVICE TECHNICIAN REPAIRED THE DEVICE ON SITE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO (B)(4) TECHNICAL SERVICES. DURING THE REVIEW OF THE EVENT HISTORY, IT WAS DISCOVERED THAT A BATTERY DEPLETED SET ALARM OCCURRED DURING INFUSION, WHICH CAUSED AN INTERRUPTION DURING DELIVERY. THERE IS NO FURTHER COMPLAINT INFORMATION AVAILABLE. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.08.92, CATEGORIZED AS REMEDIATED.

    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