BEUDAMED
    FDA Adverse Event Summary report: N

    1423500-2010-04494

    MDR report key: 1871835 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04494
    Date Received
    October 16, 2010
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE PERITONITIS WAS DUE TO POOR ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND FOUND TO BE ADEQUATE. A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBERS (H10F28014, H10E07085, H10E30046), WITH NO DEFECTS NOTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE IN 2009, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS WHICH DID NOT INVOLVE HOSPITALIZATION. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR ESCHERICHIA COLI AND CANDIDA ALBICANS. THE NURSE DID NOT PROVIDE INFORMATION REGARDING TREATMENT. IT WAS NOT REPORTED WHETHER PD THERAPY WAS ONGOING AT THE TIME OF THE EVENTS. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENTS OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR ESCHERICHIA COLI AND FUNGAL PERITONITIS WITH CULTURE POSITIVE FOR CANDIDA ALBICANS WERE NOT RELATED TO PD THERAPY. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION WITH REGARDS TO PD THERAPY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO THAT PRIOR TO CLOSING THE PACEMAKER POCKET DURING THE INITIAL IMPLANT PROCEDURE, THIS ATRIAL DEXTRUS LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND THE POCKET WAS CLOSED. FOUR HOURS LATER, AN X-RAY REVEALED THE LEAD HAD DISLODGED A SECOND TIME. THEREFORE, THE PACEMAKER POCKET WAS RE-OPENED AND THE DECISION WAS MADE TO EXPLANT THE LEAD. A NEW LEAD WAS IMPLANTED WITHOUT FURTHER INCIDENT. THE LEAD WAS NOT RETURNED FOR TESTING. THEREFORE, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 DIANEAL PD4 AMBUFLEX