BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2033011 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03822
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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). PER THE COMPLAINT INFORMATION, THE PATIENT STATED THERE WAS AIR IN THE PATIENT LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF A SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE OF THE AIR. 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 SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES NEEDING ASSISTANCE STARTING OVER WITH NEW SUPPLIES ON THE HOME CHOICE (HC) UNIT DURING FILL. THE HP STATED HE CONNECTED TO THE HC AND THEN NOTICED A LOT OF AIR BUBBLES IN THE PATIENT LINE. HE STATED HE STARTED PRESSING BUTTONS AND NOW HAS THE HC IN FILL 4/19. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER, END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO MEDICAL INTERVENTION OR INJURY WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE; PER THE CARE GIVER (CG), THE SUPPLIES WERE DISCARDED, BUT THE LOT NUMBER WAS GIVEN. THE CG STATED THEY DID NOT CONTACT THE PD RN REGARDING THE AIR IN THE TUBING, BUT WILL LET HER KNOW. THE CG STATED THEY WERE INSTRUCTED BY THE TSR TO START OVER WITH NEW SUPPLIES. THE CG STATED THEY STARTED OVER WITH NEW SUPPLIES AND THE HP RESUMED THERAPY WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 H11B01050

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR HOMECHOICE