BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1598131 · Received February 11, 2010

    Report

    Report Number
    1423500-2010-00115
    Event Type
    Injury
    Date Received
    February 11, 2010
    Date of Event
    September 1, 2009
    Report Date
    September 15, 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

    (B)(4). ADDITIONAL INFORMATION: THE SAMPLES FOR COMPLAINTS (B)(4) AND (B)(4) WERE DISCARDED BY THE CUSTOMER AND THEREFORE WERE NOT AVAILABLE FOR EVALUATION. A TOTAL OF NINE USED MINISET TEST SAMPLES WERE SENT FROM THE (B)(4) CLINIC TO THE BAXTER (B)(4) RENAL DIVISION COMPLAINT LAB IN (B)(6)/(B)(6) 2009. THESE NINE SAMPLES WERE NOT COMPLAINT SAMPLES BUT WERE SAMPLES (B)(6) 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 (B)(6) THROUGH (B)(6) 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) COMPLAINT 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 #26304 (PGS 180-189) AND #26716 (PGS 145-155, 160-173). TEST RESULTS ON FIVE OF THE MINISET SAMPLES SHOWED NO GROWTH, WHILE THE FOUR OTHER MINISET SAMPLES SHOWED THE FOLLOWING GROWTHS: PATIENT (B)(6) - STAPHYLOCOCCUS EPIDERMIS ISOLATED FROM THE WHITE TWIST SLEEVE AND BLUE MAINBODY/OCCLUDER LEGS; PATIENT (B)(6) - ACINETOBACTER BAUMANNII, DELFTIA ACIDOVORANS, PSEUDOMONAS LUTEOLA, AND RHIZOBIUM RADIOBACTER - ALL ISOLATED FROM THE WHITE TWIST SLEEVE AND BLUE MAINBODY/OCCLUDER LEGS; PATIENT (B)(6) - STAPHYLOCOCCUS HOMINIS ISOLATED FROM THE BLUE MAINBODY/OCCLUDER LEGS AND SYNCEPHALASTRUM RACEMOSUM ISOLATED FROM THE WHITE TWIST SLEEVE AND BLUE MAINBODY/OCCLUDER LEGS; PATIENT (B)(6) - CHAETOMIUM GLOBOSUM ISOLATED FROM THE WHITE TWIST SLEEVE.

    Additional Manufacturer Narrative · 1

    (B) (4). NO ACTUAL OR COMPANION SAMPLES ARE AVAILABLE FOR EVALUATION FOR THIS PATIENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THERE IS OFTEN INSULIN AND BLOOD BENEATH THE ADHESIVE OF THE INFUSION SITE. THE PATIENT STATED THE INFUSION SITE HAD BEEN IN USE FOR 2 DAYS AND HE NOTICED ELEVATED BLOOD GLUCOSE AND HE CHANGED THE INFUSION SET. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF UP TO 322 MG/DL. THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 100-150 MG/DL. NO FURTHER INFORMATION IS AVAILABLE. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED BY BAXTER PRODUCT SURVEILLANCE ON 9-15-2009, DURING A TELECONFERENCE WITH THE FACILITY, THE NURSE MANAGER OF THE DIALYSIS UNIT STATED 4 PATIENT'S (PATIENT 1 (B) (4)) (PATIENT 2 (B) (4)) (PATIENT 3 (B) (4)) (PATIENT 4 THIS COMPLAINT) REPORTED DAMPNESS COMING OUT OF THE TUBING AND ACCUMULATION OF FLUID IN THE MINI CAP TWIST CLAMP IN USE BY THE PATIENTS AT THAT TIME. THE NURSE STATED THE FACILITY HADN'T REALLY SEEN THIS ISSUE AS FREQUENTLY IN THE PAST AND SUSPECTED THAT PATIENTS WEREN'T BRINGING IT TO THE HOSPITAL'S ATTENTION IN THE PAST. SHE CONTINUED TO SAY THAT MORE PATIENTS ARE HAVING THE MOISTURE ISSUE AND THE HOSPITAL HAS MODIFIED ITS NURSING PRACTICE TO PREVENT THE ISSUE. THE NURSE ADVISED ANOTHER PATIENT EXPERIENCED AN INFECTION AT THE EXIT SITE ((B) (4)) THAT SHE BELIEVES WAS AS A RESULT OF THIS ISSUE. THE FACILITY PHYSICIAN STATED IT WAS DIFFICULT TO DETERMINE IF THE INFECTION WAS FROM THE SHOWER HEAD WATER OR A LEAK FROM THE PRODUCT. ADDITIONAL INFORMATION RECEIVED FROM THE NURSE ON 02/03/2010 INDICATES THE FACILITY HAS SPOKEN TO OTHER BAXTER REPRESENTATIVES REGARDING THE TRANSFER SET ISSUE AND A TELECONFERENCE CALL WILL BE SCHEDULED IN THE NEAR FUTURE REGARDING THE OUTCOME. SHE STATED THAT WHEN SHE INITIALLY NOTICED THE REPORTED PROBLEM, SHE CHANGED THE TRANSFER SET FOR THE PATIENTS THAT WERE AFFECTED AND SENT THE SAMPLES IN FOR A CULTURE AND EVALUATION. THIS PATIENT WILL BE ANTIBIOTICS FOR 6 MONTHS. IT IS UNKNOWN WHEN ANTIBIOTIC THERAPY WAS STARTED AND WHAT ANTIBIOTICS WERE PROVIDED TO THE PATIENT. THE PATIENT DEVELOPED MYCOBACTERIUM GROWTH AND WAS POSITIVE FOR AFB (ACID FAST BACILLI). THE DATE OF THE CULTURE IS UNKNOWN. SHE STATED THAT THE HP IS RESUMING PD THERAPY AND DECLINED HEMODIALYSIS THERAPY. THE LOT NUMBER OF THE PRODUCT IS UNKNOWN. THE PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT IS OPENED FOR PATIENT NUMBER 4. ADDITIONAL INFORMATION RECEIVED FROM THE FACILITY NURSE MANAGER AND THE PERITONEAL DIALYSIS NURSE ON 02/05/2010 INDICATES THE FOLLOWING: THIS PATIENT EXPERIENCED AN INFECTION AT THE EXIT SITE OF THE CATHETER RELATED TO REPORTED DAMPNESS COMING OUT OF THE TUBING AND AN ACCUMULATION OF FLUID IN THE MINI CAP TWIST CLAMP. THE NURSE CLARIFIED THAT THIS PATIENT'S CATHETER EXIT SITE WAS INITIALLY CULTURED ON (B) () 2009 AND WAS POSITIVE FOR MYCOBACTERIUM CHELONA (ABSCESSUS). A CONSULT WAS DONE BY AN INFECTIOUS DISEASE PHYSICIAN WHO ORDERED THE ANTIBIOTIC THERAPY REGIME BASED ON HIS PROTOCOL FOR MYCOBACTERIUM GROWTH. THE PATIENT WAS INITIALLY STARTED ON INTRAVENOUS (IV) ANTIBIOTICS (UNKNOWN) AS WELL AS CIPRO (DOSE UNKNOWN), CLARITHROMYCIN 500MG AND DOXYCYCLINE 100MG FOR ONE MONTH. BLOOD CULTURES WERE TAKEN ON (B) (6) 2009 AND SHOWED NO GROWTH. HOWEVER, ANOTHER CULTURE WAS TAKEN OF THE EXIT SITE AND WAS POSITIVE FOR MYCOBACTERIUM CHELONA (ABSCESSUS). THE CIPRO AND IV ANTIBIOTICS WERE DISCONTINUED AFTER ONE MONTH, HOWEVER THE CLARITHROMYCIN 500MG AND DOXYCYCLINE 100MG (ORALLY) WILL CONTINUE FOR A TOTAL OF 6 MONTHS OF THERAPY. A CULTURE OF THE EXIT SITE WAS TAKEN ON (B) (6) 2010 AND WAS NEGATIVE FOR GROWTH. THE PATIENT REMAINS ON ORAL ANTIBIOTIC THERAPY AT THIS TIME. THE RECOMMENDATION TO THE PATIENT AT THE TIME OF THE INFECTION WAS TO HAVE THE PERITONEAL CATHETER REMOVED, DISCONTINUE PERITONEAL DIALYSIS AND START HEMODIALYSIS. THE PATIENT DECLINED TO HAVE THE CATHETER REMOVED, DECLINED HEMODIALYSIS AND HAS REMAINED ON PERITONEAL DIALYSIS WITH THE SAME CATHETER INTACT. THE PATIENT STATUS AT THIS TIME INDICATES THAT SHE IS DOING WELL. NO ACTUAL OR COMPANION SAMPLES ARE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention (B) (4) DIANEAL PD-2, SINGLE BAG DEXTROSE 1.50%...