BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2024230 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03414
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 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). THE ACTUAL SAMPLE IS NOT AVAILABLE; HOWEVER; A COMPANION SAMPLE WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. A BATCH REVIEW WILL BE PERFORMED ON THE REPORTED LOT NUMBER. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) 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 BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H10K29013) WITH NO ISSUES NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REPORTED RECEIVING SYSTEM ERROR 2240 (AIR IN LINE) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DWELL 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND EXPLAINED THE AIR ALARM. THE TSR ADVISED THE HP TO NOTIFY THE NURSE OF THE ALARM. THE HP DID NOT SEE ANY AIR IN THE LINES OR LEAKS. PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011. THE PATIENT STATED THAT HE DID NOT OBSERVE ANY DEFECTS WITH THE SUPPLIES. THERAPY WAS FINISHED WITH MANUALS. THE NURSE WAS CONTACTED AND NOTIFIED OF THE EVENT AND THERAPY HAS RESUMED. 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 H10K29013

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR HOMECHOICE