BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022450 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03298
    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). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. 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 HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DWELL 4 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT A SE 2240 ALARM INDICATES AIR ENTERED THE SET UP. THE TSR INSTRUCTED THE HP TO CLOSE CLAMPS AND CYCLE POWER TO CLEAR ALARM. THE HP CONFIRMED TO FINISH THERAPY WITH MANUAL SUPPLIES. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. ON (B)(6) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT HE BELIEVED THE CAUSE OF THE ALARM MAY BE RELATED TO THE BAG. HE STATED THAT THE BAG WAS CONDENSED MORE THAN USUAL. HE DID NOT FIND ANYTHING ABNORMAL WITH THE CASSETTE. THERE WAS NO INJURIES OR MEDICAL INTERVENTION 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 66 YR HOMECHOICE PRO