BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1831996 · Received September 13, 2010

    Report

    Report Number
    1423500-2010-03349
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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). THIS IS NUMBER 3 OF 4 COMPLAINTS SUBMITTED FOR THE REPORT OF PERITONITIS. AS THE PATIENT DISCARDS SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHO STATED THAT HE WAS DIAGNOSED WITH PERITONITIS AT THE BEGINNING OF (B)(6) 2010. THE HP WAS ON ANTIBIOTICS FOR THE PERITONITIS, TAKEN WITH 1000ML OF SOLUTION INTRAPERITONEALLY AND LEFT IN FOR 6.5 HOURS. THE PERITONITIS HAS SINCE RESOLVED. DUE TO THE PERITONITIS, THE PATIENT STATED HIS BLOOD SUGAR AND BLOOD PRESSURE HAVE NOT BEEN RIGHT, BUT NOW HE IS GETTING BACK ON THE RIGHT TRACK. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    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.

    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 72 YR Required Intervention