BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2822665 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04291
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 13, 2012
    Report Date
    October 13, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AIR IN TUBING (WITHOUT ALARM) WAS CONFIRMED BECAUSE IT WAS REPORTED THAT THE PATIENT DID NOT CLOSE THE CLAMPS ON ALL UNUSED LINES. THE ASSIGNABLE CAUSE CODE WAS USE ERROR -PATIENT LEFT THE UNUSED CLAMP OPEN. A LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE PREVENTION OF THE USE/USER ERROR RELATED TO THIS INCIDENT. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A LOW DRAIN VOLUME(LDV) ALARM WHILE ON HOME CHOICE (HC) DEVICE, THE HOME PATIENT (HP) THOUGHT THAT THERE WAS AIR IN THE PATIENT LINE. THIS REPORT ADDRESSES THE ISSUE OF AIR INTUBING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE THE CLAMPS, DISCONNECT AND END CYCLE POWER. THE HC ALARMED WITH 'POWER RESTORED/ INITIAL DRAIN." THE HP STATED THAT THE CLAMPS WERE OPEN ON THE SUPPLY LINE THAT HE DID NOT USE. THE TSR EXPLAINED THAT ANY LINE NOT BEING USED SHOULD BE CLOSED DURING PRIMING AND THERAPY. THE TSR ASSISTED THE HP TO END THERAPY AND GETTING THE SET OUT. THE TSR EXPLAINED THE HP WILL HAVE TO START OVER WITH NEW SUPPLIES. THE TSR RECOMMENDED THAT THE HP CONTACT THE REGISTERED NURSE(RN) REGARDING THE AIR IN LINE ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HOME PATIENT (HP) WAS CONTACTED ON (B)(4) 2012. THE HP STATED THAT THEY HAD SPOKEN TO THEIR NURSE REGARDING THE AIR. THE HP DISCARDED THE SUPPLIES, DID NOT HAVE A COMPANION SAMPLE, AND DID NOT KNOW THE LOT NUMBER. SINCE THEN, THERAPY HAS BEEN GOING WELL. THERE WAS PATIENT INVOLVEMENT BUT NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE