BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2052388 · Received April 12, 2011

    Report

    Report Number
    1423500-2011-04429
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 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). EVALUATION SUMMARY: THE SAMPLE FOR THE REPORT OF A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS RECEIVED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB, THEREFORE, THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DWELL 5 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CYCLE POWER. THE TSR EXPLAINED THE ALARMS. THE HP WILL DISCARD SUPPLIES AND FINISH WITH MANUALS. THE HP WILL NOTIFY THE NURSE OF THE ALARM. PRODUCT SURVEILLANCE (PS) CONTACTED THE HP ON (B)(4) 2011. THE HP STATED THAT THEIR EXTRANEAL BAG WAS STILL FULL AND THEY FINISHED THERAPY MANUALLY. THE HP STATED THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE HP STATED HE NOTIFIED HIS NURSE OF THE 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 H10L16067

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HOMECHOICE