BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 2152285 · Received July 7, 2011

    Report

    Report Number
    1423500-2011-08751
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 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 SYSTEM ERROR 2240 ALARM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THERE WAS AN ALLEGATION OF DEVICE MALFUNCTION REPORTED BY THE CUSTOMER; SAMPLE WAS UNAVAILABLE AND A BATCH REVIEW WAS NOT CONDUCTED SINCE LOT NUMBER WAS NOT PROVIDED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED (B)(4) AND (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE; THEREFORE, NO EVALUATION COULD BE PERFORMED, AND AN ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE (HC), DURING USE DURING THE INITIAL DRAIN. THE HOME PATIENT (HP) STATED THEY HAD DISCOMFORT DURING THE INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE THE POWER ON THE HC. THE HC DISPLAYED SE 2367. THE TSR ASSISTED THE HP TO CYCLE POWER ON THE HC. THE HC PROCEEDED TO PRESS GO TO START. CYCLING THE POWER CLEARED THE SE 2240 AND SE 2367. THE TSR HAD THE HP START OVER WITH ALL NEW SUPPLIES. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(4) 2011 REGARDING THE ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED; HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, THEY DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT THEY WERE DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT THEY HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR HOMECHOICE CYCLER