BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2962494 · Received February 14, 2013

    Report

    Report Number
    1416980-2013-03854
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    August 1, 2012
    Report Date
    January 24, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12E25069 AND H12D02046 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE REPORTED PROBLEMS WERE NOT CONFIRMED AND NO CAUSE COULD BE DETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 1 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS THE SAME PATIENT AS IN (B)(4). IT WAS REPORTED THAT A PATIENT IN THE USA EXPERIENCED PERITONITIS, SEPSIS, AND A PULLING FEELING COINCIDENT THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. DURING HOSPITALIZATION, THE PATIENT EXPERIENCED SEPSIS. THE NURSE CONFIRMED THAT THE PERITONITIS WAS THE CAUSE OF THE SEPSIS. THE PATIENT WAS TREATED WITH CEPHALOSPORIN AND VANCOMYCIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR THE PERITONITIS. ON A LATER DATE, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS CONSIDERED THAT THE PULLING WAS RELATED TO THE POSITIONING OF THE CATHETER AND THAT THE PERITONEAL MEMBRANE MIGHT NOT HAVE POSSIBLY HEALED FROM THE PERITONITIS YET. TREATMENT RENDERED WAS NOT REPORTED. THE PATIENT RECOVERED FROM THE EVENT OF PERITONITIS AND SEPSIS. THE OUTCOME FOR THE EVENT OF PULLING WAS NOT REPORTED. PER THE NURSE, THE EVENTS OF PERITONITIS AND SEPSIS WERE UNRELATED TO DIANEAL THERAPY. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PULLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66111 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE