BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2141687 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08411
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 2, 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 DEVICE HAS BEEN REQUESTED, BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RECEIVED FOR THE SYSTEM ERROR 2240 ALARM. THE REPORTED SYSTEM ERROR 2240 ALARM COULD NOT BE CONFIRMED. THE CAUSE WAS UNDETERMINED. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DWELL 6 OF 6. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CHECK LINES AND BAGS. THE HP DID NOT FIND LEAKS OR SOURCE OF AIR. THE UNUSED SUPPLY LINE CLAMP WAS CLOSED. THE TSR HAD THE HP CYCLE POWER AND DISCONNECT USING ASEPTIC TECHNIQUE. THE HP WILL NOTIFY THE NURSE REGARDING MISSED THERAPY. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP DID NOT SEE ANYTHING UNUSUAL WITH THE SUPPLIES AND DID NOT KNOW HOW AIR ENTERED THE SETUP. THE HP CONTACTED HIS NURSE REGARDING THE ALARM. THE HP SAID EVERYTHING HAS BEEN WORKING FINE SINCE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS 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 H11B17114

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR HOMECHOICE