BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1905721 · Received November 23, 2010

    Report

    Report Number
    1423500-2010-06120
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED ON POTENTIALLY RELATED LOT NUMBERS (GD876482, GD877290), WITH NO DEFECTS NOTED.

    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. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON (B)(6) 2010 THE PATIENT WAS DIAGNOSED WITH PERITONITIS. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED DUE TO THE PERITONITIS. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED, RESULTS UNKNOWN. THE NURSE STATED THAT THE "PATIENT HAD INFECTION ALREADY" AND THAT TEST RESULTS ARE NOT KNOWN YET. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENT. DIANEAL THERAPY WAS ONGOING AT THE TIME OF THE EVENT. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. THE NURSE HAD NO FURTHER INFORMATION TO PROVIDE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A RIGHT BUNDLE BRANCH BLOCK AND ANOTHER MANUFACTURER'S THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). IT WAS REPORTED THAT THIS IMPLANTABLE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS OVERSENSING THE P-WAVE AND LED TO PACING INHIBITION. THERE WAS NO SPECIFIC TIME PERIOD PROVIDED REGARDING THE LENGTH OF THE PACING INHIBITION OR IF THIS PATIENT WAS PACEMAKER DEPENDENT. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI-CAP, DISCONNECT W/PVP-1SOLUTION DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R