BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3182298 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16145
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP INFORMATION WAS RECEIVED FROM A CONSUMER AND BY A NURSE.. ON AN UNKNOWN DATE IN (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE PATIENT EXPERIENCED PERITONITIS WHILE IN THE HOSPITAL. DURING THE PREVIOUSLY REPORTED HOSPITALIZATION IN (B)(6) 2013, THE PATIENT WAS TREATED WITH UNKNOWN ANTIBIOTICS, BUT THE PERITONITIS WAS NOT GOING AWAY. ON AN UNREPORTED DATE AT THE END OF (B)(6) 2013, THE PATIENT WAS TRANSFERRED TO A REHABILITATION FACILITY. ON AN UNREPORTED DATE, THE PERITONITIS SYMPTOMS BECAME WORSE (NO SPECIFIC SYMPTOMS REPORTED) AND THE PATIENT WAS RE-HOSPITALIZED (DATE NOT REPORTED) AND WAS BEING TREATED (SPECIFICS NOT REPORTED). THE PATIENT REMAINED HOSPITALIZED. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2013, THE PATIENT EXPERIENCED RECURRENT PERITONITIS AND WAS READMITTED TO THE HOSPITAL. ON AN UNKNOWN DATE IN (B)(6) 2013, THE DIANEAL AND EXTRANEAL WAS STOPPED AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE PATIENT WAS RECOVERING FROM THE RECURRENT PERITONITIS.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT NUMBER H12K12033 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 2. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. THE CAUSE OF PERITONITIS WAS UNKNOWN. SIXTEEN DAYS LATER, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281899 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R UNSPECIFIED DIABETES MEDICATION.| DIANEAL PD4 2.5% AMBUFLEX, EXTRANEAL VIAFLEX| DIANEAL AND EXTRANEAL