BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1935535 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07140
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 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 WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    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 A SUPPLY BAG FELL AND DISCONNECTED. THE PATIENT EXPLAINED THAT THE BAG FELL BECAUSE HE TYPICALLY PUT A BOX NEXT TO HIS NIGHTSTAND TO "EXTEND IT" AND HAVE MORE ROOM FOR SUPPLIES. THE PATIENT FORGOT AND THE BAG ENDED UP SLIDING OFF THE NIGHTSTAND. 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 (B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 2 OF 5. THE PATIENT EXPLAINED THAT A SUPPLY BAG FELL AND DISCONNECTED. (B)(4) HAD THE PATIENT CYCLE POWER AND EXPLAINED THEY WOULD NEED TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED THE BAG FELL BECAUSE HE TYPICALLY PUT A BOX NEXT TO HIS NIGHTSTAND TO "EXTEND" IT AND HAVE MORE ROOM FOR SUPPLIES. THE PATIENT FORGOT AND THE BAG ENDED UP SLIDING OFF THE NIGHTSTAND. THE PATIENT DID NOT NOTICE ANY DEFECTS WITH THE SUPPLIES. THE PATIENT EXPLAINED THAT HE IMMEDIATELY CAPPED EVERYTHING OFF AND DISCONNECTED HIMSELF. THE PATIENT DID NOT START A NEW THERAPY BECAUSE IT WAS SO LATE AND NOTIFIED HIS NURSE. THE PATIENT STATED HE WAS TREATED WITH PROPHYLACTIC 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

    Patients

    Seq Age Sex Outcome Treatment
    1