BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1831492 · Received September 10, 2010

    Report

    Report Number
    6000001-2010-03132
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION CONFIRMED THE REPORTED CONDITION OF WOULD NOT DELIVER. THE ROOT CAUSE COULD WAS DETERMINED TO BE A SEPARATED MOTOR. THE MOTOR WAS REPLACED TO REPAIR THE REPORTED CONDITION. SERVICE HISTORY REVIEW DETERMINED THAT THE DEVICE HAD NOT BEEN SERVICED BY BAXTER PRIOR TO THIS EVENT. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED BECAUSE THE MANUFACTURING DATA CARD WAS DISCARDED PER RETENTION PERIOD REQUIREMENTS. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE INACCURATE LOW WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INFUSOR DEVICE WHICH WOULD NOT DELIVER, DUE TO STRIPPED GEARS DURING BIOMEDICAL TESTING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED HER BLADDER EMPTYING COMPLETELY WHILE SHE WAS SLEEPING. THIS HAS OCCURRED 3 TIMES AND SHE DID NOT WAKE UP ON ANY OF THE OCCASIONS. IT WAS NOTED THAT SHE WAS TAKING MEDICATIONS FOR SLEEPING AND THAT HER DEVICE WAS WORKING "WONDERFULLY" FOR HER. INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT WAS REPROGRAMMED AND CONFIRMED THE SYMPTOMS OF LACK OF THERAPEUTIC EFFECT. THE DEVICE SYSTEM WAS EXPLANTED AND NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1