BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2150647 · Received July 6, 2011

    Report

    Report Number
    1423500-2011-08704
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 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 SPECIFIC PRODUCT CODE FOR THE HOMECHOICE AUTOMATED PD SET WITH CASSETTE IS UNKNOWN. THE DEVICE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED; HOWEVER PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE WHEN THERAPY WAS INITIATED. THE CAUSE WAS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER (B)(4) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. PER THE INITIAL REPORT, THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240. THE CAREGIVER (CG) STATED THAT HER (B)(6) NIECE PRESSED GO BEFORE THE HP CONNECTED AND THE HP DID NOT REALIZE IT. THE HP STILL CONNECTED AND THAT WAS WHEN THE ALARM SOUNDED. THE TSR EXPLAINED THE ALARMS AND HAD THE CG CYCLE THE POWER TWICE TO CLEAR THEM. THE TSR THEN EXPLAINED THAT THE CG WOULD NEED TO START OVER WITH NEW SUPPLIES AND ADVISED THE HP TO CALL THE NURSE (RN) IN THE NEXT 24 HOURS AND LET THE RN KNOW WHAT HAPPENED. THE CG UNDERSTOOD THE EXPLANATIONS. BAXTER (B)(4) CONTACTED THE CG ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE CAUSE OF THE ALARM WAS DUE TO GO BEING PRESSED BEFORE THE HOME PATIENT WAS CONNECTED THEN THE HP CONNECTING. THE CG VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER CG, THE HOME PATIENT DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE CG STATED THAT THE HP WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES.

    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 59 YR HOMECHOICE