BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1930217 · Received December 16, 2010

    Report

    Report Number
    1423500-2010-06932
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 25, 2010
    Report Date
    November 25, 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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: 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 ENTER INTO THE DISPOSABLE SET. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS UNKNOWN. THE HOMECHOICE APD SYSTEMS PATIENT AT HOME GUIDE INSTRUCTS PATIENTS ON HOW TO DISCONNECT FOR A SHORT TIME PERIOD IN AN EMERGENCY. A LABELING REVIEW WAS PERFORMED AND FOUND 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).

    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 DRAIN 5 OF 5. THE PATIENT STATED SHE DISCONNECTED TO USE THE RESTROOM AND THEN RECONNECTED. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. GTS ADVISED THE PATIENT TO DISCARD THE SUPPLIES AND FINISH THERAPY WITH MANUAL SUPPLIES. PRODUCT SURVEILLANCE MADE CONTACT WITH THE PATIENT. THE PATIENT STATED THE SUPPLIES WERE DISCARDED AND THE LOT NUMBER WAS NOT KNOWN. THE PATIENT HAD RESUMED THERAPY WITH MANUAL SUPPLIES WITHOUT ANY PROBLEMS. THE PATIENT STATED THAT SHE DID NOTIFY HER DIALYSIS NURSE. 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 47 YR HOMECHOICE PRO APD CYCLER (B)(4) (REFURBISHED)