BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3133040 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13565
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: GD893891, GD893990 AND GD893867 AND NO ISSUES WERE DETECTED DURING THE MANUFACTURE OF THESE LOTS. (B)(4). SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPIES WERE ONGOING. AS A RESULT OF THE PERITONITIS, THE PATIENT EXPERIENCED DIARRHEA AND STOMACH ISSUES. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS AND THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED PROPHYLACTIC ANTIBIOTICS FOR THE PERITONITIS. ON A LATER DATE, THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235894 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention FLEXICAP, MINICAP TRANSFER SET| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, DIANEAL PD4 AMBUFLEX