BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2142237 · Received June 28, 2011

    Report

    Report Number
    1423500-2011-08424
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 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 THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL 4 OF 4 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. SIMILAR REPORTS HAVE BEEN RECEIVED 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 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 (B)(4) TO REPORT A SYSTEM ERROR (SE) 2240 WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING DWELL 4 OF 4 .THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HELPED THE HOME PATIENT (HP) TO CLEAR THE ERROR AND EXPLAINED THE MEANING OF THE SE 2240. THERE WERE NO LEAKS AND ALL BAGS WERE CONNECTED AS PER THE HP . THE HP WILL CALL THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) FOR INSTRUCTIONS ON COMPLETING THE LAST FILL. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, (B)(4) SPOKE WITH HOME PATIENT (HP) REGARDING THE SE 2240. THE HP DID NOT KNOW WHAT MIGHT HAVE CAUSED THE ALARM. THE HP HAD INFORMED THE NURSE ABOUT THE ALARM AND WAS ABLE TO COMPLETE THERAPY AT THAT TIME. THE HP HAS BEEN CONTINUING THERAPY WITH NO FURTHER ISSUES. THE SUPPLIES WERE DISCARDED AND THE LOT NUMBER WAS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 PRO