BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1980216 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01566
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 17, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER REVIEW OF COMPLAINT INFORMATION, IT HAS BEEN DETERMINED THAT THIS INCIDENT INVOLVES THE DRUG BAG AND NOT THE DEVICE; THEREFORE, THIS INCIDENT HAS BEEN DETERMINED NOT TO BE A MDR REPORTABLE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF THIS PERITONITIS EPISODE IS UNKNOWN, AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE RECEIPT OF FURTHER INFORMATION AND COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER'S GLOBAL PHARMACOVIGILANCE PERITONEAL DIALYSIS (PD) BAGS WITH HOLES (QUANTITY UNKNOWN) AND THE PATIENT HAD BEEN DIAGNOSED WITH PERITONITIS. NURSE WAS UNCERTAIN IF THE PD SOLUTION WAS CAUSALLY RELATED. ON (B)(6) 2011, BAXTER CONTACTED THE DIALYSIS NURSE (PDRN) WHO WAS WITH THE HOME PATIENT(HP) IN THE CLINIC AT THE TIME OF THE CALL. THE HP STATED THAT THE ONSET OF CHILLS AND UPSET STOMACH OCCURRED ON (B)(6) 2011. HE CAME TO THE CLINIC THE NEXT DAY WHERE PERITONEAL EFFLUENT WAS OBTAINED. TREATMENT STARTED IMMEDIATELY WITH ANCEF AND CEFTAZIDIME, EACH 1GM DAILY INTRAPERITONEALLY(IP) FOR 14 DAYS. ON (B)(6) 2011, PD FLUID WAS RECULTURED. TREATMENT WITH ORAL CIPROFLOXIN 200MG TWICE DAILY WAS THEN INITIATED FOR 4 WEEKS. THE HP CONTINUED TREATMENT AT THE TIME OF THIS REPORT AND RECOVERY WAS ONGOING BUT IMPROVED. THE HP AND THE PDRN GAVE CAUSALITY TO THE AMBUFLEX PD2 SOLUTION. THE HP STATED THAT ON THE DAYS PRIOR TO THE ONSET OF HIS SYMPTOMS, HE HAD USED PD SOLUTION FROM 2 INDIVIDUAL BOXES WHICH HAD EXCESSIVE MOISTURE ON THE INSIDE OF THE OUTER PACKAGING, MAKING THE SOLUTION BAG WET. THE HP HAS BEEN ON AUTOMATED PERITONEAL DIALYSIS FOR GREATER THAN 1 YEAR WITH AMBUFLEX (REG CAL) PD2 SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention AMBUFLEX (REG CAL) PD2| HOME CHOICE CYCLER