BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2223682 · Received August 25, 2011

    Report

    Report Number
    1423500-2011-11274
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) OCCURRED DURING INITIAL DRAIN WAS CONFIRMED; PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS THAT THE PATIENT LEFT THE CLAMP ON PATIENT LINE CLOSED DURING PRIMING. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. THE LOT NUMBER IS UNKNOWN AT THIS TIME; THEREFORE A BATCH REVIEW WILL NOT BE CONDUCTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING SYSTEM ERROR (SE) 2240 (AIR IN THE SET) DURING THE INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE AIR ALARM. THE CAREGIVER (CG) STATED DURING THE INITIAL DRAIN, SHE NOTICED SHE FORGOT TO OPEN THE CLAMP ON EXTENSION LINE. THE TSR EXPLAINED THAT THE LINE WAS FULL OF AIR AND THAT IT WAS NOT PRIMED PROPERLY. THE TSR INSTRUCTED THE CG TO CYCLE POWER TWICE TO GET BACK TO PRESS GO. THE CG WOULD START OVER WITH NEW SUPPLIES AND WILL NOTIFY THE REGISTERED NURSE (RN) ABOUT ALARM. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING THE ALARM. THE RN WAS MADE AWARE THAT THE HP DID NOT OPEN THE CLAMP TO THEIR EXTENSION LINE WHEN THEY PRIMED THE MACHINE. THE RN STATED THE HP HAS HAD NO INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THERE WAS PATIENT INVOLVEMENT.

    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 73 YR HOMECHOICE