BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1963063 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00745
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    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) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. 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 BATCH REVIEW STATED THAT EXCEPTION ISSUES WERE NOTED DURING MANUFACTURING FOR A POSSIBLE HOLE IN THE TUBING. A PRODUCT NONCONFORMANCE WAS ASSOCIATED WITH THIS MANUFACTURING BATCH. ROOT CAUSE INVESTIGATION INDICATED AN EQUIPMENT MALFUNCTION, IN WHICH CORRECTIVE ACTION WAS TAKEN TO ADJUST THE EQUIPMENT TO MEET SPECIFICATION REQUIREMENTS. THE AFFECTED PRODUCT FOR POSSIBLE HOLE IN TUBING WAS REJECTED PER ROUTINE PROCEDURES AND 100% VISUALLY INSPECTED. THE PRODUCT RE-INSPECTIONS MET QUALITY REQUIREMENTS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 2 OF 4. GTS ASSISTED, THE HOME PATIENT (HP) TO RECYCLE THE HC AND EXPLAIN THE ALARM. GTS INFORMED THE HP TO START OVER USING NEW SUPPLIES. DURING FOLLOW UP, THE HP'S WIFE STATED THEY DID NOT KNOW HOW AIR MIGHT HAVE GOTTEN IN THE LINE. THE HP'S WIFE STATED THAT THEY DID NOTIFY THE NURSE OF THE ALARM. THE WRITER SPOKE WITH THE HOME PATIENT'S (HP) WIFE ON (B)(6) 2010 REGARDING THE REPORTED PROBLEM. THE HP'S WIFE STATED, THEY DID NOT KNOW HOW AIR MIGHT HAVE GOTTEN IN THE LINE. THEY DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE HP'S WIFE STATED, THEY HAD A LITTLE TROUBLE WITH THE PROGRAMMING ON THE MACHINE AFTER BUT THAT IT WAS ALL WORKED OUT AND THEY WERE RESUMING THERAPY WITHOUT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10I17037

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HC CYCLER