BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2080351 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05597
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 13, 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). THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB ON THE NINETEEN COMPANION SAMPLES RECEIVED IN ORIGINAL PACKAGING IN REFERENCE TO OVER-PRIME LEAK OUT OF PATIENT LINE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE SETS WERE PLACED ON A HOMECHOICE (HC) MACHINE FOR PRIMING WITH NO ALARMS NOTED. NO MANUFACTURING ABNORMALITIES WERE NOTED DURING VISUAL INSPECTION. A ROOT-CAUSE WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 13 OF 15 ASSOCIATED WITH THIS ISSUE. PER THE CUSTOMER THE SAMPLE WAS DISCARDED; HOWEVER, 15 COMPANION SAMPLES WERE AVAILABLE AND REQUESTED FOR EVALUATION. 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

    A CUSTOMER CONTACTED BAXTER TO REPORT ALL CASSETTES FROM ONE BOX WERE LEAKING FROM THE PATIENT'S LINE. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP), IT WAS REVEALED THAT THE PATIENT LINE LEAKED WHEN HE WAS PRIMING THE HOMECHOICE (HC) MACHINE; IT DRIPS RIGHT WHERE THE PATIENT SHOULD GET CONNECTED. THE HP ALSO STATED THAT IT LEAKS FOR A LITTLE BIT AFTER THEY GET CONNECTED, RIGHT AT THE CONNECTION SITE. THEY ARE NOT SURE WHY THIS KEEPS OCCURRING. THE HP STATED THAT THE THERAPY HAD BEEN GOING WELL OTHERWISE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE CAREGIVER (CG) REGARDING THE OVERPRIMING ISSUES, IT WAS REVEALED THAT THE ISSUE HAS NOT BEEN RESOLVED YET. THE CG EXPLAINED THAT SHE HAD USED 15 CASSETTES FROM THE BOX, WHICH LEAKED FROM THE TOP OF THE PATIENT LINE DURING PRIMING. THE CG DENIED STACKING BAGS ON TOP OF EACH OTHER. UPON EXPLAINING ABOUT THE HEIGHT OF THE TUBING DURING PRIMING, THE CG STATED THAT SHE DID NOT KNOW SHE HAD TO VERIFY THAT THE HEIGHT OF THE PATIENT LINE HAD TO BE AT THE SAME LEVEL AS THE TOP OF THE HEATER BAG DURING PRIMING; HOWEVER, THE CG COULD NOT CONFIRM THAT THE HEIGHT OF THE TUBING WAS NOT APPROPRIATE DURING ANY OF THE ABOVE EVENTS. THE CG HAD DISCUSSED THE ISSUE WITH THE NURSE, WHO WAS NOT SURE OF THE CAUSE EITHER. PRODUCT SURVEILLANCE SUGGESTED THE CG TO HAVE THE NURSE OBSERVE THEM PERFORM PRIMING, SO THE NURSE CAN VERIFY THAT PROPER PROCEDURES ARE BEING FOLLOWED. THE CG WAS ALSO ADVISED TO CALL THE TOLL FREE NUMBER LOCATED ON THE HC CYCLER, WHEN THEY HAVE ISSUES WITH THERAPY. THE CG DID NOT NOTICE ANY DEFECTS ON THE CASSETTES. PER CG, HP IS DOING FINE AND CONTINUING THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 H11B17031

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR HOMECHOICE