BEUDAMED
    FDA Adverse Event Death Summary report: N

    LITE NEGATIVE PRESSURE WOUND THREAPY PUMP

    MDR report key: 2735710 · Received August 31, 2012

    Report

    Report Number
    1419937-2012-00319
    Event Type
    Death
    Date Received
    August 31, 2012
    Date of Event
    August 3, 2012
    Report Date
    August 8, 2012
    Manufacturer
    MEDELA, AG
    Product Code
    OMP
    PMA / PMN Number
    K080357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS CURRENTLY IN BIOHAZARD STORAGE AT THE LONG TERM CARE FACILITY AND WILL BE RETURNED TO THE MANUFACTURER ON (B)(6) 2012. A COPY OF THE VOLUNTARY MEDWATCH WHICH WAS FILED BY THE LONG TERM CARE FACILITY IS INCLUDED WITH THIS FILING. A FOLLOW UP REPORT WILL BE FILED AFTER RECEIPT OF THE PUMP TO REPORT THE RESULTS OF TESTING/ANALYSIS. THE FOLLOWING INFORMATION WAS OBTAINED VIA A TELEPHONE CALL ON (B)(6) 2012 (9 AM CST) WITH THE NURSE MANAGER AT THE LONG TERM CARE FACILITY WHERE THE PT WAS BEING TREATED. THE PT INVOLVED WAS A (B)(6) MALE RESIDING AT THE EXTENDED CARE UNIT (B)(6) SINCE (B)(6) 2012. THE PT WAS IN A MOTOR VEHICLE ACCIDENT SEVERAL YEARS AGO WHICH CAUSED POST TRAUMATIC BRAIN INJURY LEAVING THE PT DEBILITATED. HE WAS CARED FOR BY CAREGIVERS IN THE HOME UNTIL HE BEGAN FALLING SO FREQUENTLY THAT HIS SAFETY WARRANTED ADMISSION TO A (B)(6) IN (B)(6) 2012. OTHER DIAGNOSIS INCLUDE: INSULIN DEPENDENT DIABETES, HYPOGLYCEMIA WITH HYPOGLYCEMIC SEIZURES, CHRONIC BACK PAIN, SEIZURE DISORDER, RECURRENT DEEP VEIN THROMBOSIS, DEPRESSION, ANXIETY WITH PSYCHOSIS, HYPONATREMIA, SEPSIS AND BENIGN PROSTATIC HYPERTROPHY. PERTINENT SURGICAL HISTORY INCLUDES INITIAL I&D OF LEFT GROIN ABSCESS IN 2009. THIS ABSCESS REOCCURRED AND "OPENED UP" AGAIN IN (B)(6) 2012 AND ON (B)(6) 2012 AN INCISION AND DRAINAGE AND DEBRIDEMENT OF LEFT GROIN WOUND WAS PERFORMED. NO HISTORY OF VASCULAR SURGERY OR TRAUMA TO THE LOWER EXTREMITIES. PERTINENT MEDICATIONS INCLUDE LEVOQUIN 750MG, SLIDING SCALE INSULIN. PT WAS NOT ON ANY ANTICOAGULANT, NSAIDS OR ASA AT TIME OF NEGATIVE PRESSURE WOUND THERAPY (NPWT) APPLICATION. (B)(6). PT WAS ON AN ADA DIET AND "NOT ALWAYS COMPLIANT". RECENT CBC; WBC-4.74, RBC-3.8, HCT-10.8, HGB-34, PLT 218. PAST WOUND TREATMENT: WET TO DRY GAUZE DRESSINGS, DAKINS SOLUTION MOISTENED GAUZE. WOUND ASSESSMENT: LOCATION: LEFT GROIN WOUND AT UPPER INNER THIGH. DIMENSIONS: LENGTH 8CM X WIDTH 4CM X DEPTH 5CM (WITH "CAVITY AT 2-3 O'CLOCK") NO TUNNELING OR UNDERMINING DOCUMENTED. WOUND BED: (B)(6) 2012 MEDICAL RECORD STATES THICK NECROTIC TISSUES AT BASE. EDGES RED. REST OF WOUND BED HEALTHY WITH SEROSANGUENOUS DRAINAGE; (B)(6) 2012 PER (B)(6) CLINICIAN BEEFY RED WITH YELLOW SLOUGH PRESENT. RECENT WOUND CULTURE: GRAM NEGATIVE RODS E, AEROGENES. TREATED WITH LEVOQUIN. NEGATIVE PRESSURE WOUND THERAPY: PHYSICIAN ORDER: NPWT AT 80MMHG CONTINUOUS, CHANGE DRESSING EVERY 72 HOURS. DEBRIEF: THE EXTENDED CARE UNIT HAD NOT USED NPWT IN SEVERAL YEARS. THE (B)(6) CLINICIAN WAS PRESENT FOR THE INITIAL NPWT DRESSING APPLICATION. A RN PERFORMED THE DRESSING CHANGE WHICH INCLUDED CLEANSING THE WOUND, WRAPPING THE DRAIN IN SEVERAL LAYERS OF THE AMD GAUZE AND PLACING IT INTO THE BASE OF THE WOUND. NO NON-ADHERENT WOUND CONTACT LAYER WAS APPLIED TO THE WOUND BED PRIOR TO PLACING DRAIN. GAUZE WAS PLACED OVER THE DRAIN, THE OSTOMY STRIP WAS APPLIED AROUND DRAIN TUBE AT WOUND EDGE, COVER DRESSING APPLIED, TUBING CONNECTED TO THE INVIA PUMP, 300CC CANISTER CONNECTED TO PUMP, INVIA LITE PUMP POWERED ON AND SET AT 80MMHG CONTINUOUS. THE DRESSING COMPRESSED AND NO LEAK WAS NOTED. WITHIN 1 MINUTE SEROSANGUENOUS FLUID WAS SEEN IN WOUND. THE DRESSING WAS MONITORED EVERY SHIFT. ON (B)(6) 2012 AT 12PM, SMALL AMOUNT OF SANGUENOUS DRAINAGE WAS DOCUMENTED. THE ATTENDING PHYSICIAN DOCUMENTED THE PT'S CAUSED OF DEATH AS CARDIAC ARREST RELATED TO SEPSIS AND RENAL FAILURE. ACCORDING TO THE (B)(6) CLINICIAN, WHO PROVIDED THE PUMP TO THE LONG TERM CARE FACILITY AND COMPLETED AN IN-SERVICE: ON (B)(6) 2012, I TRAVELED TO THE EXTENDED CARE FACILITY TO IN-SERVICE THE NURSING STAFF ON THE EXTENDED CARE FLOOR. WE, AT THE (B)(6), HAD RECEIVED A REFERRAL FROM THE TREATING PHYSICIAN. UPON ARRIVAL AT THE HOSPITAL, I MET WITH THE DIRECTOR OF MATERIAL MANAGEMENT. SHE SIGNED FOR THE EQUIPMENT AND TOOK ME TO THE EXTENDED CARE FLOOR WHERE I WAS INTRODUCED TO THE (B)(6) NURSE MANAGER. I BEGAN TO INSTRUCT HER AND FOUR OTHER NURSES ON THE USE OF THE MEDELA INVIA WOUND HEALING SYSTEM. I DISCUSSED WITH THEM THE INDICATIONS AND CONTRAINDICATIONS OF NPWT. INSTRUCTED ON THE PRESSURE SETTINGS, USING ADMINISTRATIVE MODE, BATTERY LIFE, ALARMS AND HOW TO RESPOND APPROPRIATELY. I LET THEM HEAR THE SOUND OF THE ALARM AND HAD THEM DEMONSTRATE HOW TO SILENCE IT. WE WENT OVER PLACING THE DOUBLE-LUMEN TUBING AND CANISTER. SEVERAL NURSES DEMONSTRATED HOW TO APPLY AND REMOVE BOTH THE TUBING AND CANISTER WITHOUT DIFFICULTY. AT THIS POINT, I INSTRUCTED ON THE DIFFERENT DRESSING KITS AVAILABLE BOTH FOAM AND GAUZE, ALONG WITH THE COMPONENTS OF EACH KIT. WE THEN PROCEEDED TO THE PT'S ROOM. UPON ENTERING, WE IDENTIFIED THE PT AND OURSELVES. I OBSERVED THE NURSE PERFORM THE DRESSING CHANGE PROCEDURE UTILIZING THE 15 FR ROUND CHANNEL DRAIN. THE PT'S WOUND WAS LOCATED ON HIS UPPER LEG/GROIN AREA. HIS WOUND WAS BEEFY RED IN COLOR WITH YELLOW SLOUGH PRESENT. THE WOUND HAD A TUNEL AT THE 2 O'CLOCK POSITION. THE PT TOLERATED THE DRESSING CHANGE WELL AND NEGATIVE PRESSURE WAS INITIATED AT -80MMHG. ALL OF THE NURSES PRESENT VERBALIZED AN UNDERSTANDING OF THE PROCEDURE AND HOW TO OPERATE THE PUMP. THE CONTACT INFORMATION FOR THE (B)(6) WAS PLACED IN THE PT'S CHART, ALONG WITH THE OPERATION MANUAL FOR THE INVIA WOUND HEALING SYSTEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CUSTOMER SERVICE THAT A HEALTH-COMPROMISED PT IN A LONG TERM CARE FACILITY WAS PLACED ON THE NEGATIVE PRESSURE WOUND THERAPY (NPWT) PUMP ON (B)(6) 2012 TO TREAT A GROIN WOUND THAT HE HAD SUSTAINED IN 2009 FROM A CAR ACCIDENT. ON (B)(6) 2012, THE NURSES WERE IN THE ROOM TALKING WITH THE PT AND HE WAS WATCHING TELEVISION - TEN MINUTES LATER THEY HEARD THE PUMP ALARM, WENT INTO THE ROOM AND FOUND THE PT DEAD WITH BLOOD ON THE FLOOR. THE CUSTOMER INDICATED THAT THE PUMP WAS SET AT 80MMHG AND WAS BEING USED WITH THE 10FR ROUND CHANNEL DRESSING SET, HOWEVER, THE WOUND CONTACT LAYER WAS NOT USED. THE CUSTOMER DID NOT KNOW WHEN OR IF THE DRESSING WAS CHANGED ON (B)(6) 2012, IF THE CANISTER WAS FULL WHEN THE PUMP ALARMED, OR IF THE PT WAS ON ANY MEDICATIONS. THE CUSTOMER STATED THAT THE LONG TERM CARE FACILITY IS RETAINING THE PUMP AND ACCESSORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LITE NEGATIVE PRESSURE WOUND THREAPY PUMP OMP MEDELA, AG 78710

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death