BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1860651 · Received October 7, 2010

    Report

    Report Number
    1423500-2010-04113
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED BASED ON INFORMATION AVAILABLE IN THIS COMPLAINT REPORT. A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBERS (GD876482 AND GD874842 ), WITH NO DEFECTS NOTED. 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

    THE SURGEON REPORTED: "AFTER VITRECTOMY FLUID/AIR EXCHANGE WAS ACTIVATED VIA THE AUTOMATIC F/AX VALVE. NO AIR CAME INTO THE EYE. ALL TUBING WAS EXAMINED FOR KINKING ETC. BSS WAS INFUSED INTO THE EYE AGAIN. THAT WORKED AND F/AX WAS INITIATED ONCE MORE, STILL WITHOUT ANY SUCCESS. THERE WAS NO HARM TO THE PATIENT AND SURGERY WAS COMPLETED WITHOUT PERFORMING THE F/AX." ADDITIONAL INFORMATION WAS REQUESTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED AND DIAGNOSED WITH PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNREPORTED. IT WAS UNREPORTED WHETHER TREATMENT WAS PROVIDED. PD THERAPY WAS ONGOING. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAD RECOVERED FROM THE PERITONITIS.

    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 51 YR Hospitalization| R