BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2511720 · Received March 30, 2012

    Report

    Report Number
    1423500-2012-07555
    Event Type
    Malfunction
    Date Received
    March 30, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 3, 2012
    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 REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED AND THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS PROVIDED, A BATCH REVIEW WILL BE PERFORMED.

    Description of Event or Problem · 1

    DURING TROUBLE SHOOTING OF A CHECK LINES AND BAGS ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. PER THE CAREGIVER (CG) AID SHE TRIED PRIMING TWO TIMES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HELPED THE CG CHECK FOR FLOW FROM THE SUPPLY BAG AND HEATER BAG. PER THE CG THE OTHER WHITE CLAMP WAS CLOSE BUT WAS DRIPPING. THE TSR ASKED THE CG REPLACE THE CASSETTE AND BAG AND START OVER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED CAREGIVER (CG) ON (B)(6) 2012 REGARDING THE LEAK. THE CG REPORTED THAT THE ISSUE WAS RESOLVED ENDING THERAPY ON THE CYCLER AND HAVING THE HOME PATIENT (HP) CONTINUE THERAPY WITH MANUALS. THE CG SHE DID NOT KNOW THE CAUSE OF THE LEAK. THE CG SAID SHE HAD CLOSED THE CLAMP. THE CG DID NOT SEE ANY NOTICABLE DAMAGE ON THE UNUSED SUPPLY LINE. PER CG, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP WAS NEVER CONNECTED. THE CG STATED THAT THE HP WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE CG 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 H11H30031

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR HOMECHOICE