BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2032748 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03788
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 6, 2011
    Report Date
    March 6, 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). THIS COMPLAINT WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DWELL 3 OF 4. THE HOME PATIENT (HP) WAS STILL CONNECTED AND THE SUPPLY BAG WAS EMPTY. THERE WAS SOLUTION IN THE HEATER BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF ANY BAG HAD BECOME UNDONE. THE HP STATED "NO". THE TSR EXPLAINED THE ALARM AND HELPED THE HP CLEAR THE ALARM BY TURNING HC OFF AND ON. SE 2367 OCCURRED. THE TSR HAD THE HP TURN THE HC OFF AND ON AND PRESS BACK TO "PRESS GO TO START". THE HP WILL FINISH THERAPY WITH MANUAL BAG. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HP CONTACTED THE WRITER ON (B)(6) 2011 REGARDING THE REPORTED ALARM AND HE STATED THAT HE RESUMED ON MANUALS AND WAS ABLE TO COMPLETE THERAPY. HE STATED HE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES AT THE TIME AND HAS SINCE DISCARDED THEM. HE DOES NOT RECALL THE LOT NUMBER AND STATED THAT HE WAS NOT SURE WHAT CAUSED THE ALARM. HE STATED HE HAS NEVER HAD THAT ALARM BEFORE AND WILL BE FOLLOWING UP WITH HIS NURSE ABOUT IT. HE STATED THERAPY IS GOING WELL AND REPORTED NO INJURY OR MEDICAL INTERVENTION.

    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 HOMECHOICE