BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW RECIRCULATION VOLUME APOSET W/CASSETTE

    MDR report key: 1811771 · Received August 23, 2010

    Report

    Report Number
    1423500-2010-02790
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 2 OF 3 ASSOCIATED WITH THIS EVALUATION. THREE COMPANION SAMPLES WERE RECEIVED IN ORIGINAL PACKAGING AND NOT OPENED; SETS WERE PLACED ON HOMECHOICE (HC) MACHINE FOR PRIMING AND RUN WITH NO ALARMS NOTED. THIS COMPLAINT FOR THE SYSTEM ERROR (SE) 2240 (AIR IN LINE) COULD NOT BE CONFIRMED IN THE LAB. THE CAREGIVER (CG) NOTICED FLUID ON THE FLOOR AND EXPLAINED THAT SHE LATER DISCOVERED THERE WERE ABRASION / LACERATION ON THE CASSETTE TUBING. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. THE BATCH REVIEW WAS PERFORMED ON LOT (H10B02067) WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE USED SAMPLE WAS DISCARDED BY CUSTOMER, HOWEVER, 3 UNUSED SAMPLES WERE AVAILABLE, AND REQUESTED FOR EVALUATION.A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY NECESSARY SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE DISPLAY DURING DRAIN 3 / 12. THE HOME PATIENT (HP) HAD NOT DISCONNECTED SINCE THE START OF THERAPY. UPON NOTICING FLUID ON THE FLOOR, THE CAREGIVER (CG) INSPECTED THE PATIENT LINE AND FOUND THAT THE LINE WAS DAMAGED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG DISCONNECT THE HP USING ASEPTIC TECHNIQUE, TROUBLESHOOT THE ALARM AND END THERAPY. THE CG AGREED TO NOTIFY THE PERITONEAL DIALYSIS NURSE BEFORE STARTING OVER WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE CG REGARDING THE LEAK AND THE ALARM, THE CG EXPLAINED THAT SHE LATER DISCOVERED THERE WERE ABRASION / LACERATION ON THE CASSETTE TUBING. THE CG ADDED THAT THE SOURCE OF THE LEAK WAS THE ABRASION. THE CG STATED THAT SHE HAD OPENED 2 MORE CASSETTES FROM THE SAME BOX, AND FELT WITH HER FINGER TIPS PRIOR TO SETUP, AND FOUND THE SAME PROBLEM. THE CG STATED THAT SHE THEN TRIED A CASSETTE FROM A DIFFERENT BOX, AND FOUND NO DEFECTS AND HAD NO ISSUES DURING THERAPY. PER CG, SHE DID NOTIFY THE NURSE, EFFLUENT CULTURE WAS PERFORMED, AND THE RESULTS CAME BACK WITHOUT GROWTH. THE CG CONFIRMED THAT THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. PER CG, HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. (SECOND OF 3 EMDRS)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOW RECIRCULATION VOLUME APOSET W/CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10B02067

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR