BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE PRE P1.7

    MDR report key: 2091912 · Received May 17, 2011

    Report

    Report Number
    6000001-2011-04160
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    March 1, 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
    OTHER

    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. THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS DEPLETED MAIN BATTERIES. THE MAIN BATTERIES AND HARNESS HAVE BEEN REPLACED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FIELD CORRECTIVE ACTION NUMBER HAS BEEN PROVIDED IN SECTION H9. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4).

    Description of Event or Problem · 1

    BAXTER FIELD SERVICE TECHNICIAN SERVICED A COLLEAGUE DEVICE, PRODUCT CODE DNM9163, SN (B)(4), FOR A BATTERY ISSUE. THE PROCESS STEP WAS UNKNOWN AND NO PATIENT INJURY IS 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 BAXTER'S 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. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 6.63.92, CATEGORIZED AS REMEDIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE PRE P1.7 PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1