BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022746 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03345
    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). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER, PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. A LOT NUMBER WAS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    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) HAD QUESTIONS ON A SYSTEM ERROR (SE) 2240 IN DWELL 3 OF 4. THE HP DISCONNECTED AND WENT BACK TO BED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM. HP REMOVED THE CASSETTE AND BAG FROM THE HC. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE WRITER CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP SAID HE KEEPS THE BAGS ALL LAYERED PROPERLY AND MADE SURE THE CONNECTIONS WERE TIGHT. THE HP SAID HE WENT OVER THE SUPPLIES AND EVERYTHING LOOKED PROPER. HE DID NOT KNOW HOW AIR GOT INTO THE LINE. THE HP SAID THE LOT NUMBER WAS UNKNOWN AND NO SAMPLE WAS AVAILABLE. THE HP SAID EVERYTHING WAS WORKING FINE NOW AND IT WAS ALL TAKEN CARE OF. THE 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 PD CYCLER