BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2024298 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03425
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED FROM THE PERITONEAL DIALYSIS (PD) NURSE. THE PATIENT'S RECENT FREQUENCY OF PD4 ULTRA BAG WAS 2 FILLS DAILY. LOT NUMBERS AND DOSE FOR THE PD4 AMBUFLEX WAS NOT AVAILABLE. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR A SECOND INCIDENT OF YEAST PERITONITIS. TREATMENT AND INTERVENTIONS WERE NOT REPORTED. OUTCOME FOR THE PERITONITIS WAS NOT REPORTED. IT WAS UNKNOWN AT THE TIME OF THE REPORT WHAT SPECIFIC YEAST GREW IN THE PERITONEAL EFFLUENT CULTURE. ON AN UNKNOWN DATE IN 2011, IT WAS DISCOVERED THE PATIENT HAD YEAST ON HIS HEART. IT WAS UNKNOWN HOW THIS EVENT WAS DIAGNOSED, HOWEVER, THE PD NURSE SUSPECTED THROUGH A TRANSESOPHAGEAL ECHOCARDIOGRAM(TEE) (UNSPECIFIED). IT WAS UNKNOWN WHICH OCCURRED FIRST THE YEAST PERITONITIS OR YEAST ON THE HEART. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, THE PATIENT DIED, CAUSE OF DEATH REPORTED AS HEART PROBLEMS, LOW HEMOGLOBIN AND HEMACRIT AND YEAST ON THE HEART VALVES. OUTCOME FOR THE PERITONITIS WAS NOT REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER H10G26065 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF (B)(6) INFECTION IN PERITONEAL CATHETER AND (B)(6) PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL, UNKNOWN, AND DIANEAL PD4 ULTRABAG THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL, UNKNOWN, AND DIANEAL PD4 ULTRABAG (LOT NUMBERS, DOSES, AND FREQUENCIES NOT REPORTED) INTRAPERITONEALLY (IP) FOR AUTOMATED PERITONEAL DIALYSIS (APD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S WIFE REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT DEVELOPED A (B)(6) INFECTION IN THE PERITONEAL CATHETER. THE WIFE REPORTED ONE OF THE DRAIN BAGS WAS ALL BLOOD AND ANOTHER BAG WAS "REALLY GROSS, LOOKED LIKE FIBRIN". UPON A FOLLOW-UP CALL WITH THE PATIENT'S NURSE, THE NURSE REPORTED THAT THE PATIENT WAS ON BACTRIM DS ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED) SINCE (B)(6) 2010 FOR PREVENTATIVE MAINTENANCE AND THEN THE PATIENT GOT A (B)(6) INFECTION (ONSET NOT REPORTED). ON (B)(6) 2011, THE PATIENT DEVELOPED PERITONITIS AND WAS NOT HOSPITALIZED. TREATMENT FOR THE PERITONITIS AS REPORTED BY THE CONSUMER WAS TAKING A (B)(6) PILL EVERYDAY. ON AN UNREPORTED DATE, DIANEAL THERAPIES WERE STOPPED AND WERE RESTARTED ON (B)(6) 2011. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE OUTCOME FOR THE YEAST INFECTION IN THE PERITONEAL CATHETER WAS NOT REPORTED. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE (B)(6) PERITONITIS WAS NOT RELATED TO DIANEAL THERAPIES. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE (B)(6) INFECTION IN THE PERITONEAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death| H| R DIANEAL PD4 ULTRABAG| DIANEAL| PD4 AMBUFLEX