BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3132386 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13520
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS GD894170 AND GD894014, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF THESE BATCHES. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT, ABDOMINAL DISCOMFORT, STOMACH PAIN, FEVER, AND CHILLS. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE THE PT RECEIVED TREATMENT FOR THE PERITONITIS WITH GENTAMICIN AND CEFAZOLIN, IP, (DOSES, FREQUENCIES, AND LOTS UNKNOWN). CONCOMITANT THERAPY WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS UNKNOWN IF THE PT WAS RETRAINED IN ASEPTIC PROCEDURES FOR PD THERAPY. PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT , THE PT WAS RECOVERING FROM THE PERITONITIS. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235589 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention DIANEAL PD4, 2.5% , LOW CALCIUM AMBUFLEX| FLEXICAP| HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4, LOW CALCIUM ULTRABAG| MINICAP TRANSFER SET