BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022636 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03326
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WAS NOT CONDUCTED. THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED; HOWEVER, PER THE COMPLAINT INFORMATION THE ROOT CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THERE WAS AN OPEN CLAMP ON UNUSED SUPPLY LINE. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) REPORTED A SYSTEM ERROR (SE) 2240 IN DWELL 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE ALL THE CLAMPS AND TRANSFER SET AND CYCLE POWER. THE HC ALARMED WITH SE 2367. POWER WAS CYCLED AGAIN TO PRESS GO TO START. THE TSR EXPLAINED THE ALARM. THE HP STATED SHE LEFT THE SPARE SUPPLY LINE CLAMP OPEN. THE TSR EXPLAINED TO DISCARD ALL OF THE SUPPLIES AND REPORT THE ALARMS TO THE PERITONEAL DIALYSIS NURSE (PDN) IN THE MORNING. THE HP WOULD FINISH THIS NIGHT'S THERAPY WITH MANUAL SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER CONTACTED THE HP ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM AND SHE STATED THAT SHE IS RESUMING WITH THERAPY ON MANUALS DURING THE DAY AND THE CYCLER AT NIGHT. SHE STATED THAT HER NURSE IS AWARE, AND THE HP KNOWS HOW TO SET UP CORRECTLY FOR THERAPY. SHE STATED EVERYTHING 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 PD CYCLER