BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192514 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10309
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 21, 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 REPORT OF A USE ERROR WAS NOT CONFIRMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH NCR (B)(4). A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A CHECK HEATER LINE ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) LEARNED THAT THE HOME PATIENT (HP) WAS NOT CONNECTED AT THIS TIME. THE TSR HAD THE HP RECONNECT, THEN THE HP ADVISED THAT SHE CHANGED OUT THE BAG AND STARTED THE MACHINE OVER. THE TSR CONFIRMED WITH THE HP THAT THE FRANGIBLES HAVE BEEN BROKEN, PULL DOWN ON CASSETTE TUBING, MOVE RED CLAMP 3 INCHES EITHER DIRECTION, INSPECT DRAIN LINE, INSPECT BAG PORT, FLIP HEATER BAG OVER. THE TSR HAD THE HP PRESS STOP AND GO. THE HC ALARMED CHECK LINES AND BAGS ALARM. THE TSR THEN REALIZED THAT HP MENTIONED THAT SHE CHANGED OUT THE BAG WHEN TSR QUESTIONED IF ENTIRE SET UP CHANGED OR JUST THE HEATER BAG, THE HP STATED THAT EVERYTHING WAS CHANGED OUT BUT THE RESPONSE TO THE QUESTION WAS QUITE DELAYED. THE TSR EXPLAINED ONCE STARTING OVER WITH NEW SUPPLIES THAT THE HP WOULD NEED TO BYPASS INITIAL DRAIN AS INITIAL DRAIN WAS ALREADY COMPLETED. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING HAVING TO START OVER WITH NEW SUPPLIES DUE TO A CHECK HEATER LINE ALARM. THE HP STATED THAT THEY CONTINUED THERAPY WITH HOMECHOICE (HC) USING NEW SUPPLIES. THE HP SAID SHE TRIED TO RESOLVE THE ALARM BY ONLY CHANGING OUT THE HEATER BAG. THE HC THEN ALARMED CHECK LINES AND BAGS ALARM. THE SUPPLIES HAVE BEEN DISCARDED. THE HP HAD DECLINED SENDING IN A COMPANION CASSETTE SAMPLE. THE LOT NUMBER WAS UNAVAILABLE. THE HP ALSO REPORTED THAT COULD NOT SEE ANYTHING VISIBLY WRONG WITH CASSETTE OR THE HEATER BAG AND DID NOT KNOW WHAT HAD CAUSED THE ALARM. THERAPY HAS BEEN GOING WELL SINCE INCIDENT. PER HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. NO FURTHER INFORMATION AVAILABLE. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR HOMECHOICE