BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1904512 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06080
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS NOT KNOWN; THEREFORE NO DEVICE EVALUATION OR BATCH REVIEW CAN BE PERFORMED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A PATIENT UNSPIKING A SUPPLY LINE AND RESPIKING IT INTO ANOTHER SUPPLY BAG. THE PATIENT DID THIS IN EFFORTS TO CLEAR A CHECK SUPPLY LINE ALARM. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN, THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A CHECK SUPPLY LINE ALARM THAT OCCURRED ON THE HOME CHOICE UNIT DURING LAST DWELL. THE HP HAD TAKEN IT UPON HIMSELF TO TRY TO RESOLVE THE CHECK SUPPLY LINE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) FOUND THAT THE HP HAS UNSPIKED A FULL SUPPLY BAG A RESPIKED TO THE HEATER BAG TO TRY TO RESUME THERAPY, THE HP WAS UNSURE AFTER THIS AND CALLED FOR TROUBLESHOOTING. THE TSR ADVISED THE HP TO CLOSE THE CLAMPS, DISCONNECT AND END THERAPY AS THEY WERE IN DWELL 4 OF 4 AND TO CALL THE NURSE FOR FURTHER INSTRUCTIONS. THE HP STATED HE WAS SEEING HIS NURSE IN THE MORNING. THE TSR FURTHER INFORMED THE HP TO LET THE NURSE KNOW ABOUT THE UNSPIKING AND RESPIKING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR