BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP

    MDR report key: 3033623 · Received April 3, 2013

    Report

    Report Number
    1416980-2013-08297
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 19, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBER: GD893313. A NONCONFORMANCE OCCURRED ON THE BATCH. IT IS DETERMINED THIS NONCONFORMANCE DID NOT CONTRIBUTE TO PERITONITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION RECEIVED FROM THE NURSE. THE NURSE STATED THAT SHE HAD SEEN THE PATIENT PERFORM PERITONEAL DIALYSIS (PD) THERAPY AT HOME BEFORE, AND HAD NOT OBSERVED ANY BREACH IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING AT THE TIME OF THIS REPORT

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 5. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS NOT REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL EIGHT DAYS LATER. THE PATIENT RECOVERED FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136051 MINI-CAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG