BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI-CAP, DISCONNECT W/PVP-1SOLUTION

    MDR report key: 1873355 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04599
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED, THEREFORE, NO EVALUATION WAS PERFORMED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS IS THE SECOND OF THREE COMPLAINTS RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. A BATCH REVIEW WAS PERFORMED ON LOT NUMBERS GD876482, GD877282 AND GD877274, WHICH WERE SENT TO THE CUSTOMER AROUND THE TIME OF THE INCIDENT, AND NO DEVIATIONS WERE FOUND. 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. (B)(4).

    Description of Event or Problem · 1

    DURING A CALL TO THE BAXTER TECHNICAL SERVICE CENTER FOR ASSISTANCE IN CLEARING THE PATIENT LINES, THE PATIENT REPORTED HE CURRENTLY HAD PERITONITIS. DURING A FOLLOW UP CALL ON (B)(6) 2010, THE FACILITY NURSE PROVIDED THE FOLLOWING CLINICAL INFORMATION: THE NURSE CONFIRMED THE PATIENT HAD A CONFIRMED EPISODE OF PERITONITIS ON (B)(6) 2010. THE PATIENT WAS NOT HOSPITALIZED. INTERVENTIONS INCLUDED CEFAZOLIN 1 GRAM EVERY DAY INTRAPERITONEAL (IP) (LENGTH OF THERAPY UNKNOWN) AND GENTAMYCIN 40MG IP (LENGTH OF THERAPY UNKNOWN). THE PATIENT WAS LATER CHANGED TO VANCOMYCIN 1 GRAM EVERY WEEK IP (LENGTH OF THERAPY UNKNOWN). THE PATIENT HAS RECOVERED FROM THE EVENT. THE CAUSE OF THE PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE AND TOUCH CONTAMINATION. THE PATIENT HAS BEEN RETRAINED.

    Description of Event or Problem · 1

    PHILIPS (B)(4) WAS NOTIFIED BY CUSTOMER THAT AN AED WAS DEPLOYED IN AN ATTEMPT TO RESUSCITATE TWO AVALANCHE VICTIMS. VICTIMS WERE NOT RESUSCITATED.

    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 66 YR Required Intervention