BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPUMP PAIN MANAGEMENT SYSTEMUS VERSION

    MDR report key: 1571883 · Received January 7, 2010

    Report

    Report Number
    6000001-2010-00034
    Event Type
    Injury
    Date Received
    January 7, 2010
    Date of Event
    December 17, 2009
    Report Date
    December 17, 2009
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    MEA
    PMA / PMN Number
    K052973
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SERIAL NUMBER IS UNKNOWN AT THIS TIME, AS WELL AS WHETHER THE DEVICE INVOLVED IS AVAILABLE FOR EVALUATION OR NOT.

    Additional Manufacturer Narrative · 1

    (B)(4).(B)(4) THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE SERIAL NUMBER WAS INADVERTENTLY REPORTED IN THE INITIAL MEDWATCH REPORT FOR THIS INCIDENT AS THE FACILITY DID NOT KNOW THE EXACT PUMP SERIAL NUMBER INVOLVED IN THE INCIDENT. THEREFORE, THE DEVICE MANUFACTURE DATE WAS ALSO INADVERTENTLY REPORTED IN THE INITIAL MEDWATCH REPORT FOR THIS INCIDENT. ADDITIONAL INFORMATION: AS THE FACILITY WAS UNABLE TO DETERMINE WHICH PUMP SERIAL NUMBER WAS INVOLVED WITH THIS INCIDENT AND INDICATED THAT A PUMP WOULD NOT BE AVAILABLE FOR EVALUATION, A DEVICE HISTORY REVIEW WAS PERFORMED ON TWO PUMP SERIAL NUMBERS ((B) (4) AND (B) (4) REPORTED BY THE FACILITY AS POSSIBLY HAVING BEEN THE PUMP INVOLVED. THE DEVICE HISTORY REVIEW INDICATED THAT NO EXCEPTION WAS OBSERVED DURING THE MANUFACTURING OF THESE TWO PUMPS. DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    BAXTER PRODUCT SURVEILLANCE WAS MADE AWARE OF AN ALLEGED ACCURACY ISSUE BY GLOBAL TECHNICAL SERVICES IN WHICH THE CUSTOMER RECEIVED TOO MUCH MEDICATION. INFORMATION REGARDING MEDICATION BEING ADMINISTERED IS NOT KNOWN, HOWEVER, THE PATIENT DID RECEIVE ANOTHER DRUG, NARCAN, TO COUNTERACT THE EFFECTS OF THE INITIAL MEDICATION (PATIENT'S OXYGEN LEVEL WAS LOW). THE PATIENT'S STATUS IS SAID TO BE FINE. AT THIS TIME, THE EXACT SERIAL NUMBER OF THE DEVICE IS UNKNOWN. THIS INFORMATION IS AWAITING CLARIFICATION BY THE CUSTOMER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B) (6), 2010, A DOCTOR REPORTED TO ATTACHMENTS INTERNATIONAL, INC. THAT TWO SCREWS BROKE IN A PATIENT'S MOUTH. THIS IS THE SECOND OF TWO REPORTS.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER HAS BLACK MARKS IN THE DISPLAY. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPUMP PAIN MANAGEMENT SYSTEMUS VERSION PUMP, INFUSION MEA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention