BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013724 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03013
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 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 AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 OCCURRED DURING DWELL 4 OF 4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. PER THE EVENT DESCRIPTION, THE CAREGIVER EXPLAINED THAT THE PATIENT DID NOT DISCONNECT, AND THERE WERE NO LEAKS OR UNUSED LINES. BAXTER PRODUCT SURVEILLANCE CONTACTED THE CAREGIVER WHO EXPLAINED THERE WAS A TINY HOLE IN THE CASSETTE TUBING GOING TOWARD ONE OF THE SOLUTION BAGS. THE CAREGIVER DID NOT KNOW WHAT CAUSED THE DAMAGE BUT STATED THE ONLY THING SHE COULD THINK OF WAS MAYBE WHEN THE TUBING WAS FOLDED IT CAUSED A WEAK SPOT. AN EXACT ROOT CAUSE WAS NOT DETERMINED. THE BATCH REVIEW WAS PERFORMED WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 4 OF 4. (B)(4) EXPLAINED THE ERROR INDICATED A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. THE CAREGIVER EXPLAINED THAT THE PATIENT DID NOT DISCONNECT, AND THERE WERE NO LEAKS OR UNUSED LINES. (B)(4) HAD THE CAREGIVER CYCLE POWER AND RETRIEVE THE CASSETTE. (B)(4) ADVISED THE CAREGIVER TO NOTIFY THE PATIENT'S DIALYSIS NURSE. PRODUCT SURVEILLANCE (PS) CONTACTED THE CAREGIVER WHO EXPLAINED THERE WAS A TINY HOLE IN THE CASSETTE TUBING GOING TOWARD ONE OF THE SOLUTION BAGS. THE CAREGIVER DID NOT KNOW WHAT CAUSED THE DAMAGE, BUT STATED THE ONLY THING SHE COULD THINK OF WAS MAYBE WHEN THE TUBING WAS FOLDED IT CAUSED A WEAK SPOT. THE CAREGIVER WAS ABLE TO PROVIDE THE LOT INFORMATION, BUT STATED THE SAMPLE WAS UNAVAILABLE. THE CAREGIVER FURTHER EXPLAINED THE PATIENT NOTIFIED THEIR DIALYSIS NURSE AND WAS ABLE RESUME THERAPY SUCCESSFULLY. 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 H10L01119

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR HOMECHOICE