BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243308 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12052
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 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 COMPLAINT FOR SYSTEM ERROR 2240 WAS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION, THE LOT NUMBER WAS NOT PROVIDED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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 REGARDING A SYSTEM ERROR (SE) 2267 WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE HC ALARMED WITH A SYSTEM ERROR 2267 IN DWELL 4 OF 4. THE HOME PATIENT (HP) WAS STILL CONNECTED. ONE OF THE SUPPLY BAGS HAD FALLEN AND BECAME DISCONNECTED. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HELPED THE HP TO CLEAR THE ALARM BY TURNING THE HC OFF THEN ON. THE HC WAS BACK TO PRESS GO TO START PROMPT. THE HP WOULD FINISH WITH MANUAL BAG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION BUT THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED HP ON (B)(6) 2011 REGARDING THE SE 2267 ALARM. THE HP REPORTED THAT THE ISSUE WAS RESOLVED BY ENDING THERAPY ON THE CYCLER AND FINISHING WITH MANUALS. THE HP SAID THE CAUSE OF THE ALARM WAS DUE TO THE SUPPLY BAG FALLING. THE HP DID NO KNOW WHY THE BAG HAD FALLEN. PER HP, THERE WERE NO LOOSE CONNECTIONS OR DEFECTS ON THE SUPPLIES. 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 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 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 53 YR HOMECHOICE