BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2022609 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03314
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K833065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - AS THE DATE OF ONSET OF THIS PERITONITIS EVENT IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS THE FIRST OF SIX REPORTS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4) - ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME OF THIS EVENT. ON (B)(6) 2011, BAXTER GLOBAL PHARMOCOVIGILANCE CONTACTED THE PERITONEAL DIALYSIS NURSE (PDRN) FOR A PATIENT FOLLOW UP REPORT. THE PATIENT WAS STILL HOSPITALIZED ON THE DATE OF THIS FOLLOW UP, BUT WAS RECOVERING FROM THE FUNGAL PERITONITIS. THE PDRN CLARIFIED THAT THE "MOLD" FOUND ON THE PD CATHETER TIP IN (B)(6) 2011 WAS IDENTIFIED ON A 3 DAY CULTURE AS A CURVULARIA SPECIES. THE PATIENT WAS REPORTED AS METICULOUS WITH HIS ASEPTIC TECHNIQUE WHEN PERFORMING PD THERAPY. MEDICAL HISTORY ALSO INCLUDED AORTIC VALVE REPLACEMENT, PLEURAL EFFUSIONS, ATRIAL FIBRILLATION AND FACIAL SKIN CANCER.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT H10L20077 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) WAS CONTACTED BY BAXTER ON (B)(6) 2011 REGARDING THE HOME PATIENT'S (HP) PRIOR REPORTED FILLING ISSUE. SHE STATED THE CLINIC WAS AWARE OF THE HP'S PROBLEM AND THAT THE HP WAS SEEN IN THE CLINIC (B)(6) 2011 AND SENT FOR AN EMERGENCY EVALUATION DUE TO "BLACK STUFF" COMING FROM THE PD CATHETER TIP. THE HP WAS THEN ADMITTED TO THE HOSPITAL ON (B)(6) 2011 WHERE PD EFFLUENT WAS OBTAINED FOR TESTING. THE PD CATHETER WAS REMOVED WHILE HOSPITALIZED (DATE UNKNOWN) AND THE TIP WAS CULTURED. A FUNGAL PERITONITIS WAS THEN DIAGNOSED. TREATMENT WAS INITIATED WITH AMPHOTERICIN B INTRAVENOUSLY (IV) (DOSE AND DURATION UNKNOWN). AFTER PD THERAPY WAS DISCONTINUED, HEMODIALYSIS(HD) WAS INITIATED IN (B)(6) 2011 (DATE UNKNOWN). THE OUTCOME AND HOSPITAL DISCHARGE DATE WERE NOT REPORTED. THE PDRN DID NOT GIVE CAUSALITY, BUT STATED THAT THE BAXTER DIALYSIS PRODUCTS WERE NOT SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R HOME CHOICE CYCLER| LOWCAL (PD4) ULTRABAG| LOWCAL (PD4) AMBUFLEX