BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1871861 · Received October 16, 2010

    Report

    Report Number
    1423500-2010-04488
    Event Type
    Injury
    Date Received
    October 16, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBERS (GD874842, GD874826), WITH NO DEFECTS NOTED. THE ROOT CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS COMPLAINT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON (B)(6) 2010. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE THE DEVICE WAS UNABLE TO CROSS THE LESION. ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 85% STENOSED, 2.5X20MM TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED, MODERATELY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS PREDILATED WITH A 1.5X15MM BALLOON AND THEN THE 2.5X16MM TAXUS LIBERTE STENT WAS ADVANCED TO THE LAD; HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PHYSICIAN ATTEMPTED TO CROSS THE LESION WITH A 2.5X8MM TAXUS LIBERTE STENT BUT THIS DEVICE WAS ALSO UNABLE TO CROSS THE LESION. THE PROCEDURE WAS ENDED AT THIS POINT AND THE PHYSICIAN RECOMMENDED A ROTATIONAL ATHERECTOMY PROCEDURE AT A DIFFERENT HOSPITAL. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S CONDITION IS STABLE. HOWEVER, RETURNED PRODUCT ANALYSIS REVEALED A SHAFT BREAK.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT BEGAN PERITONEAL DIALYSIS (PD) TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON (B)(6) 2010, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WITH UNKNOWN RESULTS. IT WAS UNREPORTED WHETHER TREATMENT WAS PROVIDED. IT WAS UNREPORTED WHETHER PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO PD THERAPY.

    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 44 YR Hospitalization| R