BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243307 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12049
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 22, 2011
    Report Date
    August 22, 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 REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A SYSTEM ERROR (SE) 2240 (AIR IN SET). RECEIVED ACTUAL SAMPLE IN REFERENCE TO SE 2240. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. (B)(4) ADDRESSES SYSTEM ERROR 2240 ALARMS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN LINE) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE TRANSFER SET AND ALL CLAMPS. THE TSR ADVISED HP THAT AIR HAD ENTERED THE SETUP. THE TSR HAD HP RECYCLE POWER. THE TSR ADVISED HP THAT THERAPY HAD ENDED AND THAT THEY WOULD NEED TO START OVER WITH NEW SUPPLIES OR DO MANUAL EXCHANGE. THE TSR ADVISED HP TO INFORM PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF SE 2240. THE HP WOULD DO MANUAL EXCHANGE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION BUT THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HP REPORTED THAT THE ISSUE WAS RESOLVED, BUT HE DID NOT KNOW THE CAUSE OF THE ALARM. PER HP, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP STATED THAT SHE DISCUSSED THE ALARM WITH HER NURSE. PER HP, SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE STILL HAD THE CASSETTE BUT DID NOT KNOW THE LOT NUMBER. THE HP WILL HOLD THE SAMPLE FOR EVALUATION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. 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 75 YR HOMECHOICE