BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CIDEX PLUS 28 DAY SOLUTION

    MDR report key: 1802093 · Received August 17, 2010

    Report

    Report Number
    2084725-2010-00256
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 20, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    LRJ
    PMA / PMN Number
    K923744
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: CYSTOSCOPE - BRAND AND MODEL NUMBER ARE UNKNOWN. (B)(4): PSEUDOMONAS. THIS IS ONE OF FOUR 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2010-00256, 2084725-2010-00257, 2084725-2010-00258, 2084725-2010-00259.

    Additional Manufacturer Narrative · 1

    CORRECTION: CHANGED TO EVENT TYPE TO ADVERSE EVENT DEVICE. TYPE OF REPORTABLE EVENT: SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE COMPLAINT HISTORY TRENDING, BATCH RECORD REVIEW BY PRODUCT LINE AND FAILURE MODE EFFECTS ANALYSIS. COMPLAINT HISTORY TRENDING FOR CIDEX PLUS 28 DAY SOLUTION WAS NOT PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED FROM NOVEMBER 2009 THROUGH OCTOBER 2010 FOR CIDEX PLUS 28 DAY SOLUTION WITH THE PROBLEM CODE "HR-PROCEDURE RELATED," WHICH REVEALED SIX COMPLAINTS (4 OF THE 6 ARE FROM THIS FACILITY). BATCH RECORD REVIEW OF THE CIDEX PLUS 28 DAY SOLUTION COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE FMEA (FAILURE MODE EFFECTS ANALYSIS) FOR CIDEX PLUS 28 DAY SOLUTION DID NOT COVER THIS PARTICULAR SITUATION. THERE WAS NO PRODUCT SAMPLE RETURNED FOR INVESTIGATION. THE LOT NUMBER OF THE CIDEX PLUS 28 DAY SOLUTION IS UNKNOWN. THE SOURCE OF THE INFECTION (S) WAS NOT LINKED TO CIDEX PLUS TRAYS OR TO CIDEX PLUS 28 DAY SOLUTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FOUR PATIENTS WHO WERE DIAGNOSED WITH A PSEUDOMONAS URINARY INFECTION AFTER A CYSTOSCOPY PROCEDURE PERFORMED AT THEIR FACILITY. UNSPECIFIED ORAL ANTIBIOTICS WERE ADMINISTERED TO THE PATIENTS, BUT THE BACTERIUM WAS RESISTANT. THE PATIENTS WERE LATER ADMITTED TO THE HOSPITAL. URINE AND BLOOD CULTURES CONFIRMED THE PATIENTS HAD PSEUDOMONAS. AN UNKNOWN IV ANTIBIOTIC WAS ADMINISTERED. THE PATIENTS ARE CURRENTLY IN STABLE CONDITION. THE CYSTOSCOPES USED IN THESE PROCEDURES WERE PROCESSED IN CIDEX PLUS 28 DAY SOLUTION IN CIDEX TRAYS. THE PHYSICIAN INITIALLY THOUGHT THE CIDEX PLUS 28 DAY SOLUTION OR THE CIDEX TRAYS WERE CAUSING THE PSEUDOMONAS. HOWEVER, AFTER HE OBTAINED INFORMATION FROM THE DEVICE MANUFACTURER, HE CONCLUDED THAT THE CYSTOSCOPES WERE CAUSING THE PSEUDOMONAS. THE PHYSICIAN WAS INFORMED BY THE DEVICE MANUFACTURER THAT AFTER BEING USED FOR FOUR TO FIVE YEARS, THE CYSTOSCOPES MAY HAVE RESIDUE LEFT ON THEM DUE TO THE DETERIORATION OF THE TIPS OF THE SCOPE ALLOWING THE BROWNISH MATERIALS OF THE DEVICES TO SHOW THROUGH. THE CYSTOSCOPES IN QUESTION WERE RETURNED TO THE DEVICE MANUFACTURER AND NEW CYSTOSCOPES WERE PROVIDED TO THE CUSTOMER. THE BROWNISH MATERIAL ON THE TIPS OF THE CYSTOSCOPES WAS CULTURED; HOWEVER, THE RESULTS WERE NOT PROVIDED TO ASP. IN A SUBSEQUENT CONVERSATION, THE SURGEON STATED THE SOURCE OF THE INFECTION IS NOT LINKED TO THE CIDEX PLUS 28 DAY SOLUTION OR THE CIDEX TRAYS. FOLLOW-UP ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. SHOULD FURTHER INFORMATION BE OBTAINED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED. THIS REPORT IS FOR THE FIRST OF THE FOUR PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CIDEX PLUS 28 DAY SOLUTION BIOCIDES SOLUTIONS (LRJ) LRJ ADVANCED STERILIZATION PRODUCTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1