BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE P1.7

    MDR report key: 2152802 · Received July 7, 2011

    Report

    Report Number
    6000001-2011-10764
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF "UNCONTROLLED BEEPING, UNABLE TO STOP UNLESS DISCONNECTED" WAS CONFIRMED DURING PRODUCT EVALUATION. HOWEVER, THE QUALITY ENGINEER DETERMINED FAILURE 199 TO BE THE AS DETERMINED CONDITION. THE ROOT CAUSE WAS LOOSE "EPROMS" ON THE USER INTERFACE MODULE (UIM) PRINTED CIRCUIT BOARD (PCB). THE "EPROMS" WERE REFITTED TO UIM PCB TO CORRECT REPORTED CONDITION. ADDITIONAL INFORMATION: THIS DEVICE IS A COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 8.11.00. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT A COLLEAGUE INFUSION PUMP EXPERIENCED UNCONTROLLED BEEPING, WHICH DID NOT STOP UNLESS THE PUMP WAS DISCONNECTED. THIS CONDITION HAD THE POTENTIAL TO INTERRUPT DELIVERY IT IS UNKNOWN WHEN OR IN WHICH CARE AREA THIS EVENT OCCURRED. THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THE USER INTERFACE MODULE SOFTWARE VERSION OF THIS DEVICE IS CURRENTLY UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1