BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022790 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03347
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 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). DURING A FOLLOW UP WITH THE HOME PATIENT (HP) REGARDING THE ALARM AND USE ERROR, IT WAS REVEALED THAT HE IS FINE AND CONTINUING THERAPY. THE HP STATED THAT HE AWARE OF THE PROPER PROCEDURES. NO FURTHER INFORMATION WAS PROVIDED. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE PATIENT EXTENSION LINE WAS CONNECTED AFTER PRIMING WAS COMPLETE. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) DURING INITIAL DRAIN ON THE HOMECHOICE(HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ALARM. THE HOME PATIENT (HP) MAY HAVE CONNECTED ONE OF THE EXTENSION LINES AFTER PRIMING. TSR HAD THEM CYCLE POWER AND TOLD THEM TO CALL THE NURSE ABOUT AIR ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 62 YR HOMECHOICE PD CYCLER