BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1930223 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06933
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY THE PATIENT DISCONNECTING THE PATIENT LINE FROM THE TRANSFER SET, ALLOWING AIR TO BE SUCKED IN. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS UNKNOWN. THE HOMECHOICE APD SYSTEMS AT HOME PATIENT GUIDE INSTRUCTS THE PATIENT ON HOW TO DISCONNECT FOR A SHORT AMOUNT OF TIME IN AN EMERGENCY. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT APPEARED ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CLOSE ALL CLAMPS AND TRANSFER SET, AND CYCLE POWER TWICE TO THE "PRESS GO TO START" PROMPT. TSR EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET, AND THE HP STATES HE DISCONNECTED IN DWELL 5 AND DID NOT RECONNECT IN TIME WHEN HC ENTERED DRAIN 5 CAUSING 2240 ALARM. HP THEN RECONNECTED TO PATIENT LINE. TSR EXPLAINED TO DISCARD ALL SUPPLIES AND TO REPORT ALARMS TO PERITONEAL DIALYSIS (PD) NURSE THE NEXT MORNING. HP TO FINISH TONIGHT'S THERAPY MANUALLY. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 3 MO HOMECHOICE PRO APD (B)(4) (REFURBISHED)