BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA II

    MDR report key: 2120590 · Received June 10, 2011

    Report

    Report Number
    6000001-2011-07485
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K902613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE THE REPORTED CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THAT NO EXCEPTIONS WERE NOTED DURING THE MANUFACTURING OF THIS DEVICE.

    Description of Event or Problem · 1

    BAXTER GLOBAL TECHNICAL SERVICES REPORTED ON THE CUSTOMER'S BEHALF ONE PCAII PUMP IN WHICH NON-DELIVERY OF AN UNSPECIFIED DRUG OCCURRED DURING PATIENT USE ON AN UNKNOWN DATE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED RELATED TO THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA II PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DRUG