BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1951722 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00213
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 12, 2010
    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 IS FOR A LOW DRAIN VOLUME ALARM. PER THE COMPLAINT INFORMATION, THERE WAS AIR IN THE PATIENT LINE BECAUSE THE CATHETER WAS "PLUGGED UP" AND THE HOME PATIENT STATED THAT HE WENT TO THE HOSPITAL TO GET IT FIXED. THE CAUSE WAS FOUND TO BE AIR IN PATIENT LINE. 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. THE ROOT CAUSE INVESTIGATION FOR THE LOW DRAIN VOLUME ALARMS IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER THE SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A LOW DRAIN VOLUME ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DRAIN 2 OF 4, THE HOME PATIENT (HP) REVEALED THAT HE NOTICED AIR POCKETS IN THE LINE THAT WOULD NOT MOVE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO STOP THE THERAPY FOR THAT NIGHT. THE HP WOULD NOTIFY THE PERITONEAL DIALYSIS (PD) NURSE IN THE MORNING OF THE PROBLEM. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP, IT WAS REVEALED THAT THE REASON HE HAD AIR WAS BECAUSE THE CATHETER WAS "PLUGGED UP". THE HP WAS HOSPITALIZED TO HAVE THE CATHETER ISSUE FIXED. THE HP STATED THAT HE HAD NO INJURIES AS A RESULT. THE HP STATED THAT HIS PD NURSE IS AWARE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HC CYCLER