BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2233910 · Received September 6, 2011

    Report

    Report Number
    1423500-2011-11690
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 27, 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) OCCURRED DURING INITIAL DRAIN WAS CONFIRMED; PER THE COMPLAINT INFORMATION THE CAUSE OF THE SE 2240 IS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE CAUSED BY THE PATIENT NOT CONNECTED WHEN THERAPY INITIATED. THE HP STATED HE HAD PRESSED GO NOT CONNECTED DURING THE INITIAL DRAIN, THEN CONNECTED THE PATIENT LINE, RECEIVING THE 2240 ALARM. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT REQUESTED AS THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR 2240 (AIR IN SET) DURING THE INITIAL DRAIN ON THE HOME CHOICE MACHINE WHEN THE HOME PATIENT (HP) PRESSED GO AND THEN CONNECTED TO THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLOSE ALL THE CLAMPS AND TRANSFER SET, CYCLED THE POWER OFF AND ON TWICE TO PRESS GO TO START PROMPT. THE TSR EXPLAINED THE ALARMS. THE TSR ADVISED THE HP TO DISCARD ALL SUPPLIES AND TO REPORT ALARMS TO THE PERITONEAL DIALYSIS NURSE (PDRN) THE NEXT MORNING. THE HP WOULD FINISH THAT NIGHT'S THERAPY MANUALLY. PRODUCT SURVEILLANCE (PS)CONTACTED THE HP ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. PER THE HP, HE USED MANUAL SUPPLIES TO COMPLETE THERAPY AND RESUMED THERAPY THE FOLLOWING NIGHT ON THE HOMECHOICE MACHINE. THE HP STATED HE DID NOT FOLLOW UP WITH HIS PD RN ABOUT THE ALARM. PS EXPLAINED THE ALARM AND ADVISED THE HP THAT THE ALARM MEANT THERE WAS AIR IN THE SET. THE HP STATED HE KNOWS THE PROCEDURES TO FOLLOW USING THE HOMECHOICE MACHINE. THERE WAS PATIENT INVOLVEMENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE