BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1971331 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01079
    Event Type
    Injury
    Date Received
    January 27, 2011
    Date of Event
    December 1, 2010
    Report Date
    January 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBER GD878207 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 2 INVOLVED IN THIS PERITONITIS EVENT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS AND FATAL CARDIAC DISEASE IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES. ON UNREPORTED DATES, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT THE PATIENT EXPERIENCED CARDIAC DISEASE (DATE OF ONSET NOT REPORTED). IN (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED AT THE SAME TIME. ON (B)(6) 2010, THE PATIENT DIED DUE TO CARDIAC DISEASE. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES WERE ONGOING UNTIL THE PATIENT'S DEATH. THE OUTCOME FOR THE EVENT OF PERITONITIS WAS UNKNOWN AT THE TIME OF REPORTING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENTS OF PERITONITIS AND FATAL CARDIAC DISEASE WERE NOT RELATED TO DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES.

    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 84 YR Hospitalization| O DIANEAL PD4 AMBUFLEX| DIANEAL PD4 ULTRABAG| HOMECHOICE