BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2091984 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06119
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 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 A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE CAREGIVER (CG) DID NOT KNOW HOW AIR GOT INTO THE LINES AND DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 AND SE 2367 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING INITIAL DRAIN . THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CYCLE POWER AND SE 2367 ALARMED. THE TSR ADVISED THE HP TO DISCONNECT AND RESTART WITH ALL NEW SUPPLIES. THE TSR ADVISED THE HP TO CALL THE REGISTERED NURSE(RN) IN THE MORNING. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE (PS) CONTACTED THE CAREGIVER (CG) ON (B)(4) 2011 REGARDING THE SYSTEM ERROR (SE) 2240. THE CG STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES THEY WERE ABLE TO RESUME THERAPY SUCCESSFULLY. THE CG DID NOT KNOW HOW AIR GOT INTO THE LINES AND DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE SUPPLIES IN USE. THE CG STATED THAT THEY DID NOT INFORM THE REGISTERED NURSE (RN) ABOUT THE ALARM. PS RECOMMENDED THE CG CONTACTING THE RN. THE CG STATED THERAPY HAS BEEN GOING FINE FOR THE PAST TWO NIGHTS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR