BEUDAMED
    FDA Adverse Event Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2221090 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11146
    Date Received
    August 23, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    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 IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN OVERPRIME - LEAK OUT OF PATIENT LINE WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE HOME PATIENT (HP). THE HP STATED THAT THEY HAD STACKED SOLUTION BAGS ON TOP OF EACH OTHER ON THE HEATER BAG. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    TECHNICAL SERVICE CENTER ASSISTED WITH THE REPRIMING OF THE PATIENT LINE, THIS OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING PRIME. DURING THE ASSISTANCE THERE WAS FLUID FLOWING OUT OF THE PATIENT LINE. THE PRIME COMPLETED. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THAT THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE HP WAS THEN ASKED IF THE SOLUTION BAGS WERE STACKED ON TOP OF EACH OTHER ON THE HEATER PLATE AND THE HP STATED YES. THEY WERE ALSO ASKED THE POSITIONING OF THE PATIENT LINE DURING PRIME AND THEY STATED IT USUALLY HANGS ON THE ORGANIZER DURING PRIME. THE HP STATED THEY HAVEN?T RUN INTO THIS PROBLEM SINCE THEN AND THERAPY HAS BEEN GOING WELL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE