BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1953314 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00306
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; HOWEVER, BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT WAS CONNECTED DURING PRIMING. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. REVIEW OF THE LABELING REVEALS THE HOMECHOICE APD SYSTEMS AT-HOME GUIDE CONTAINS SUFFICIENT LABELING FOR THE USER ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(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 CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH AN UNKNOWN ALARM WHILE USING THE HOMECHOICE (HC) DURING THE PATIENT'S THERAPY, IN THE INITIAL DRAIN CYCLE. THE CAREGIVER EXPLAINED THEY PRIMED THE HC WITH THE PATIENT CONNECTED AND THE HC ALARMED IN THE INITIAL DRAIN. GTS EXPLAINED THE PATIENT SHOULD NEVER BE CONNECTED WHILE PRIMING THE HC AND ASSISTED IN ENDING THERAPY. GTS THEN REVIEWED THE ALARM LOG AND FOUND A SYSTEM ERROR 2240, WHICH INDICATES AIR IN THE DISPOSABLE SET. GTS HAD THE CAREGIVER CHECK FOR LEAKS, AN OPEN CLAMP ON AN UNUSED LINE, BUT NO PROBLEMS WERE FOUND AND THE PATIENT DID NOT DISCONNECT DURING THERAPY. GTS ADVISED THE CAREGIVER TO FOLLOW-UP WITH THE PATIENT'S DIALYSIS NURSE AND SUGGESTED THE CAREGIVER CONTACT BAXTER WHEN THE HC ALARMS. PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER WHO REITERATED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE. THE CAREGIVER STATED THE PATIENT WAS ABLE TO FINISH THERAPY WITH MANUAL SUPPLIES THE FOLLOWING DAY. THE CAREGIVER THEN EXPLAINED THE PATIENT HAD FAINTED ON (B)(4) 2010, AND WENT TO THE EMERGENCY ROOM. THE CAREGIVER STATED THE PATIENT HAS VASCULAR ISSUES AND WANTED TO KNOW IF THE PATIENT COULD HAVE BEEN DEHYDRATED DUE TO THERAPY CAUSING HIM TO FAINT. THE CAREGIVER WAS ADVISED TO CONTACT THE PATIENT'S DIALYSIS NURSE OR PHYSICIAN FOR FURTHER ASSISTANCE.

    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 77 YR DIANEAL LOW CAL, SINGLE BAG DEXTROSE (B)(4) DIANEA