BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2142496 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08439
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 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 WAS DISCARDED 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). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS COMPLAINT FOR AN OVERPRIME WAS NOT CONFIRMED IN THE LAB DUE TO UNAVAILABLE SAMPLE. NO ROOT-CAUSE WAS DETERMINED. A BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER WAS NOT AVAILABLE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A ASSISTANCE FOR REPRIME WHICH OCCURRED ON HOME CHOICE (HC) DURING USE. THE HOME PATIENT (HP) REQUESTED ASSISTANCE IN REPRIME PATIENT LINE. THE HP STATED THAT THE PATIENT LINE HAD OVERFLOWED WHEN REPRIMING. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) REQUESTED AND HAD THE HP CONNECT AND START THERAPY. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(4) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) REGARDING THE ISSUES WITH OVERFLOW IN THE PATIENT LINE . THE HP DID NOT KNOW THE EXACT CAUSE ,HOWEVER HP HAD CALLED THE NURSE ABOUT IT AND THE NURSE EXPLAINED THE PROPER PROCEDURES. THE HP STATED THAT HE WAS NEW TO THE THERAPY AND HAS FINALLY STARTED TO UNDERSTAND HOW THE HC WORKS. THE HP HAD DISCARDED THE SUPPLIES AND DID NOT HAVE THE LOT NUMBER AVAILABLE. THERE WAS 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 82 YR HOMECHOICE