BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2102385 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06458
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 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 ACTUAL SAMPLE WAS DISCARDED. A COMPANION SAMPLE IS AVAILABLE. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPANION SAMPLE WAS RETURNED FOR EVALUATION. THE CASSETTE WAS PLACED ON MACHINE FOR PRIMING AND RAN WITH NO ALARMS NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED IN THE LAB. PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE BECAUSE THE HP WAS CONNECTED DURING PRIMING. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING CYCLE 2. THE HOME PATIENT (HP) STATED THAT THE ULTRAFILTRATION (UF)= - 2644ML AFTER ENDING THERAPY. THE HP HAD PRIMED WHILE CONNECTED AFTER THE ALARM WITH SAME SUPPLIES. THE HC WAS PRESENTLY AT "CONNECT YOURSELF". THE BAXTER TECHNICAL REPRESENTATIVE (TSR) EXPLAINED THE ALARMS. THE TSR TOLD THE HP TO NEVER BE CONNECTED DURING PRIMING. THE CALLER WILL DISCARD SUPPLIES AND FINISH WITH MANUALS. THE HP WILL CONTACT THE REGISTERED NURSE (RN) REGARDING THE HP BEING CONNECTED DURING AIR DETECT ALARM AND PRIMING. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE WAS CONTACTED BY THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THE FOLLOWING: NOTHING WAS KNOWN TO HAVE CAUSED THE ALARM AND THERAPY WAS FINISHED WITH MANUALS. THE SAMPLE WAS DISCARDED AND A COMPANION SAMPLE WAS AVAILABLE AND REQUESTED WITH LOT NUMBER H11A10061. THE NURSE WAS CONTACTED REGARDING THE EVENT AND THE PATIENT WAS DOING FINE WITH THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11A10061

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR