BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1941428 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07367
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 5, 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). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; HOWEVER, THE LOT INFORMATION WAS REQUESTED FOR QUALITY PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE ERROR WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE PATIENT ADVISED THEY DISCONNECTED 2-3 TIMES DURING THE DWELL, AND AIR MAY HAVE ENTERED INTO THE SYSTEM. THE BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS PATIENTS ON HOW TO DISCONNECT FOR A SHORT TIME PERIOD. THIS REVIEW FINDS THE LABELING ADEQUATE FOR THE USE ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 5 OF 6. GTS HAD THE PATIENT CLOSE ALL THE CLAMPS AND TRANSFER SET TO CYCLE POWER TWICE, CLEARING THE ERROR TO THE "PRESS GO TO START" PROMPT. GTS THEN EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. THE PATIENT ADVISED THEY DISCONNECTED 2-3 TIMES DURING THE DWELL, AND AIR MAY HAVE ENTERED INTO THE SYSTEM. GTS ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND REPORT THE ERROR TO THEIR DIALYSIS NURSE. THE PATIENT ELECTED TO COMPLETE THERAPY MANUALLY. PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT WHO PROVIDED THE LOT INFORMATION. THE PATIENT ADVISED THAT HE NOTIFIED HIS NURSE AND WAS GIVEN ANTIBIOTICS. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10B10037

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)