BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3073501 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10153
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    February 1, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FOLLOW UP INFORMATION WAS RECEIVED RELATED TO THE EVENT. IT WAS REPORTED THAT THE PATIENT WENT TO THE PD CLINIC WITH CLOUDY EFFLUENT. THE PATIENT WAS IMMEDIATELY TREATED WITH ANCEF AND FORTAZ AND WAS SENT BACK HOME TO CONTINUE WITH SCHEDULED PD THERAPY AND ANTIBIOTICS. THE PATIENT WAS LATER HOSPITALIZED FOR THE EVENTS OF WEAKNESS, A (B)(6) WEIGHT LOSS, DECREASED APPETITE, AND ABDOMINAL DISCOMFORT. THE ABDOMINAL DISCOMFORT AND CLOUDY EFFLUENT WERE CONSIDERED MANIFESTATIONS OF THE PERITONITIS. ON THE SAME DAY, THE PATIENT'S PD CATHETER WAS REMOVED. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTIC THERAPY AND WAS TRANSFERRED TO HEMODIALYSIS THERAPY INDEFINITELY. IT WAS UNKNOWN IF THE PATIENT RECOVERED FROM THE EVENTS OF WEAKNESS, WEIGHT LOSS AND DECREASED APPETITE. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS GD893743 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). ON AN UNREPORTED DATE, THE THERAPIES WERE WITHDRAWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. IT WAS REPORTED THAT THE CAUSE OF THE PERITONITIS WAS DUE TO A CATHETER RELATED ISSUE BUT FURTHER DETAILS COULD NOT BE PROVIDED. THE PATIENT RECOVERED FROM THE PERITONITIS. THE PATIENT'S CATHETER WAS REMOVED AND HEMODIALYSIS WAS INITIATED. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175070 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R HOMECHOICE, DIANEAL PD4 AMBUFLEX