BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REN - DISP - TWIST CLAMP/SLEEVE

    MDR report key: 1444510 · Received August 20, 2009

    Report

    Report Number
    1423500-2009-00384
    Event Type
    Injury
    Date Received
    August 20, 2009
    Date of Event
    July 13, 2009
    Report Date
    August 5, 2009
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K842885A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B) (4) ADDITIONAL INFORMATION: A TOTAL OF NINE USED MINISET TEST SAMPLES WERE SENT FROM THE (B) (6) CLINIC TO THE BAXTER (B) (4) RENAL DIVISION ANALYSIS LAB IN OCTOBER/NOVEMBER 2009. THESE NINE SAMPLES WERE NOT COMPLAINT SAMPLES BUT WERE SAMPLES (LABELED AS "PATIENT 001" THRU "PATIENT 009") FROM OTHER VARIOUS PATIENTS THAT WERE SENT FROM THE CLINIC TO THE RENAL DIVISION FOR IDENTIFICATION OF ANY POTENTIAL BACTERIAL GROWTH INSIDE THE TWIST SLEEVE CAVITY, WHICH IS THE AREA INSIDE AND INCLUSIVE OF THE WHITE TWIST SLEEVE AND THE LIGHT BLUE MAINBODY/OCCLUDER CLAMP. ALTHOUGH THE SAMPLES WERE RECEIVED LABELED AS "PATIENT 001" THROUGH "PATIENT 009," THERE WERE NO ALLEGATIONS OF MALFUNCTION OR DEFECT, AND THESE SAMPLES WERE COLLECTED FOR AN EXPERIMENTAL STUDY ONLY. THE NINE TEST SAMPLES WERE RECEIVED AT THE (B) (4) ANALYSIS LAB AND THEN FORWARDED ONTO THE (B) (4) MICROBIOLOGY GROUP, WHO COORDINATED ALL THE TESTING IN CONJUNCTION WITH THE BAXTER (B) (4) TESTING FACILITY AND AN OUTSIDE LABORATORY. THE MICROBIOLOGY GROUP DOCUMENTED THE TESTING WITHIN LAB NOTEBOOKS (B) (4) AND (B) (4). TEST RESULTS ON FIVE OF THE MINISET SAMPLES SHOWED NO GROWTH, WHILE THE FOUR OTHER MINISET SAMPLES SHOWED THE FOLLOWING GROWTHS: PATIENT 004 - (B) (6) ISOLATED FROM THE WHITE TWIST SLEEVE AND BLUE MAINBODY/OCCLUDER LEGS PATIENT 007 - ACINETOBACTER BAUMANNII, DELFTIA ACIDOVORANS, PSEUDOMONAS LUTEOLA, AND RHIZOBIUM RADIOBACTER - ALL ISOLATED FROM THE WHITE TWIST SLEEVE AND BLUE MAINBODY/OCCLUDER LEGS PATIENT 008 - (B) (6) ISOLATED FROM THE BLUE MAINBODY/OCCLUDER LEGS AND SYNCEPHALASTRUM RACEMOSUM ISOLATED FROM THE WHITE TWIST SLEEVE AND BLUE MAINBODY/OCCLUDER LEGS PATIENT 009 - CHAETOMIUM GLOBOSUM ISOLATED FROM THE WHITE TWIST SLEEVE.

    Description of Event or Problem · 1

    IN 2009, BAXTER WAS CONTACTED BY A SALES REPRESENTATIVE REGARDING A NURSE WHO HAD A PATIENT WITH A LEAKING TRANSFER SET. THE NURSE ALSO STATED THAT THE PATIENT DEVELOPED AN INFECTION IN THE EXIT SITE. THE NURSE STATED THE LEAK WAS BY THE LUER LOCK OF THE TRANSFER SET. THE PATIENT HAD GONE OFF OF PERITONEAL DIALYSIS AND HAD STARTED HEMODIALYSIS. THE NURSE STATED THAT SHE DID NOT KNOW SPECIFIC DATES, THE PRODUCT CODES AND LOT NUMBERS WERE UNKNOWN AND THE SAMPLE WAS DISCARDED. ON 08/14/2009, THE FOLLOWING INFORMATION WAS OBTAINED FROM THE DIALYSIS NURSE: THE PROBLEM WAS NOT A LEAK IN THE TRANSFER SET, BUT DESCRIBED AS WATER LEAKING FROM THE WHITE SLEEVE OF THE TRANSFER SET. THE NURSE EXPLAINED THAT THE PATIENT TAKES A SHOWER AND THE WATER ACCUMULATES WITHIN THE WHITE SLEEVE OF THE TRANSFER SET. THE NURSE INDICATED THAT THE WATER DOES NOT DRAIN FROM THIS AREA. THE NURSE CLARIFIED THAT THE TRANSFER SETS ARE NOT LEAKING BUT THE WATER IS BUILDING UP IN THE WHITE SLEEVE OF THE TRANSFER SET AND THEN DRIPPING OUT OF THE SLEEVE AND DOWN THE TRANSFER SET TUBING AND CATHETER AND GETS TO THE EXIT SITE WHERE IT CAUSES INFECTION. THIS PATIENT HAS AN EXIT SITE/TUNNEL INFECTION THAT WAS CONFIRMED BY CULTURE THAT GREW MYCOBACTERIUM ABSCESSUS WHICH IS A WATER BORN BACTERIUM PER THE NURSE. THE INFECTION WAS DIAGNOSED THE PREVIOUS MONTH. THE CULTURE RESULTS WERE RECEIVED BY THE NURSE A WEEK AFTER THE ORIGINAL DATE. THE PATIENT WAS TREATED WITH A LOADING DOSE OF VANCOMYCIN, 2000 MILLIGRAMS (MG) AND WILL TAKE AMIKACIN 650MG FOR SIX MONTHS. ON THE MONTH PRIOR, THE PATIENT HAD SURGERY TO REMOVE HIS PERITONEAL DIALYSIS CATHETER. ON THE NEXT DAY, THE PATIENT STARTED ON HEMODIALYSIS. THE NURSE STATED THAT THIS PATIENT HAS GOOD ASEPTIC TECHNIQUE SKILLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REN - DISP - TWIST CLAMP/SLEEVE KDJ KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention