V.A.C.® GRANUFOAM¿ DRESSING

Report

Report Number: 3009897021-2022-00163
Event Type: Injury
Date Received: October 19, 2022
Date of Event: January 18, 2021
Report Date: October 19, 2022
Manufacturer: KINETIC CONCEPTS, INC.
Product Code: OMP
PMA / PMN Number: K133276
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER WAS NOT PROVIDED AND WAS NOT RETURNED; THEREFORE, A DEVICE HISTORY RECORD REVIEW AND A DEVICE EVALUATION COULD NOT BE PERFORMED. BASED ON INFORMATION PROVIDED, KCI CANNOT DETERMINE WHEN THE FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS PLACED IN THE WOUND AND IF THE ALLEGED OSTEOMYELITIS IS RELATED TO THE V.A.C.® GRANUFOAM¿ DRESSING. THE FOREIGN MATERIAL WAS NOT RETURNED TO KCI FOR IDENTIFICATION; THEREFORE, KCI IS UNABLE TO CONFIRM ITS IDENTITY. THE FOREIGN MATERIAL WAS ALLEGEDLY LEFT IN THE WOUND FOR LONGER THAN THE MANUFACTURER'S INSTRUCTIONS PROVIDE. ADDITIONALLY, THE NURSE REPORTED THE PATIENT IS NON-COMPLIANT AND MISSED MULTIPLE APPOINTMENTS. THEREFORE, THIS EVENT IS BEING REPORTED DUE TO POTENTIAL USE ERROR. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: WARNINGS: NEVER LEAVE A V.A.C.® DRESSING IN PLACE WITHOUT ACTIVE V.A.C.® THERAPY FOR MORE THAN TWO HOURS. IF THERAPY IS OFF FOR MORE THAN TWO HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C.® DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C.® THERAPY; OR APPLY AN ALTERNATE DRESSING, SUCH AS A WET TO MOIST GAUZE, AS APPROVED DURING TIMES OF EXTREME NEED, BY TREATING PHYSICIAN. DRESSING CHANGES WOUNDS BEING TREATED WITH THE V.A.C.® THERAPY SYSTEM SHOULD BE MONITORED ON A REGULAR BASIS. IN AMONITORED, NON-INFECTED WOUND, V.A.C.® DRESSINGS SHOULD BE CHANGED EVERY 48-72 HOURS, BUT NO LESS THAN 3 TIMES A WEEK, WITHFREQUENCY ADJUSTED BY THE CLINICIAN AS APPROPRIATE. INFECTED WOUNDS MUST BE MONITORED OFTEN AND VERY CLOSELY. FOR THESE WOUNDS,DRESSINGS MAY NEED TO BE CHANGED MORE OFTEN THAN 48-72 HOURS; THE DRESSING CHANGING INTERVALS SHOULD BE BASED ON ACONTINUING EVALUATION OF THE WOUND CONDITION AND THE PATIENT'S CLINICAL PRESENTATION, RATHER THAN A FIXED SCHEDULE. FOAM PLACEMENT: ALWAYS USE V.A.C.® DRESSINGS FROM STERILE PACKAGES THAT HAVE NOT BEEN OPENED OR DAMAGED. DO NOT PLACEANY FOAM DRESSING INTO BLIND / UNEXPLORED TUNNELS. THE V.A.C.® WHITEFOAM¿ DRESSING MAY BE MORE APPROPRIATE FOR USE WITHEXPLORED TUNNELS. DO NOT FORCE FOAM DRESSINGS INTO ANY AREA OF THE WOUND, AS THIS MAY DAMAGE TISSUE, ALTER THE DELIVERY OFNEGATIVE PRESSURE OR HINDER EXUDATE AND FOAM REMOVAL. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM USED IN THE WOUND. DOCUMENT THE FOAM QUANTITY AND DRESSING CHANGE DATE ON THE DRAPE OR FOAM QUANTITY LABEL IF AVAILABLE, AND IN THE PATIENT'S CHART. FOAM REMOVAL: V.A.C.® FOAM DRESSINGS ARE NOT BIOABSORBABLE. ALWAYS COUNT THE TOTAL NUMBER OF PIECES OF FOAM REMOVED FROM THE WOUND AND ENSURE THE SAME NUMBER OF FOAM PIECES ARE REMOVED AS WERE PLACED. FOAM LEFT IN THE WOUND FOR GREATER THAT THE RECOMMENDED TIME PERIOD MAY FOSTER INGROWTH OF TISSUE INTO THE FOAM, CREATE DIFFICULTY IN REMOVING THE FOAM FROM THE WOUND OR LEAD TO INFECTION OR OTHER ADVERSE EVENTS. IF DRESSING ADHERES TO WOUND CONSIDER INTRODUCING STERILE WATER OR NORMAL SALINE INTO THE DRESSING, WAITING 15 - 30 MINUTES, THEN GENTLY REMOVING THE DRESSING FROM THE WOUND. REGARDLESS OF TREATMENT MODALITY, DISRUPTION OF THE NEW GRANULATION TISSUE DURING ANY DRESSING CHANGE MAY RESULT IN BLEEDING AT THE WOUND SITE. MINOR BLEEDING MAY BE OBSERVED AND CONSIDERED EXPECTED. HOWEVER, PATIENTS WITH INCREASED RISK OF BLEEDING, AS DESCRIBED ON PAGE 8, HAVE A POTENTIAL FOR MORE SERIOUS BLEEDING FROM THE WOUND SITE. AS A PRECAUTIONARY STEP, CONSIDER USING V.A.C. WHITEFOAM¿ DRESSINGS OR NONADHERENT MATERIAL UNDERNEATH THE V.A.C.® GRANUFOAM¿ DRESSINGS TO HELP MINIMIZE THE POTENTIAL FOR BLEEDING AT DRESSING REMOVAL IN THESE PATIENTS. INFECTED WOUNDS SHOULD BE MONITORED CLOSELY AND MAY REQUIRE MORE FREQUENT DRESSING CHANGES THAN NON-INFECTED WOUNDS, DEPENDENT UPON FACTORS SUCH AS WOUND CONDITIONS, TREATMENT GOALS. REFER TO DRESSING APPLICATION INSTRUCTIONS (FOUND IN V.A.C.® DRESSING CARTONS) FOR DETAILS REGARDING DRESSING CHANGE FREQUENCY. AS WITH ANY WOUND TREATMENT, CLINICIANS AND PATIENTS/CAREGIVERS SHOULD FREQUENTLY MONITOR THE PATIENT'S WOUND, PERIWOUND TISSUE AND EXUDATE FOR SIGNS OF INFECTION, WORSENING INFECTION, OR OTHER COMPLICATIONS. SOME SIGNS OF INFECTION ARE FEVER, TENDERNESS, REDNESS, SWELLING, ITCHING, RASH, INCREASED WARMTH IN THE WOUND OR PERIWOUND AREA, PURULENT DISCHARGE OR STRONG ODOR. INFECTION CAN BE SERIOUS, AND CAN LEAD TO COMPLICATIONS SUCH AS PAIN, DISCOMFORT, FEVER, GANGRENE, TOXIC SHOCK, SEPTIC SHOCK AND/OR FATAL INJURY. SOME SIGNS OR COMPLICATIONS OF SYSTEMIC INFECTION ARE NAUSEA, VOMITING, DIARRHEA, HEADACHE, DIZZINESS, FAINTING, SORE THROAT WITH SWELLING OF THE MUCUS MEMBRANES, DISORIENTATION, HIGH FEVER, REFRACTORY AND/OR ORTHOSTATIC HYPOTENSION OR ERYTHRODERMA (A SUNBURN-LIKE RASH). IF THERE ARE ANY SIGNS OF THE ONSET OF SYSTEMIC INFECTION OR ADVANCING INFECTION AT THE WOUND SITE, CONTACT THE TREATING PHYSICIAN IMMEDIATELY TO DETERMINE IF V.A.C.® THERAPY SHOULD BE DISCONTINUED. PRECAUTIONS: THE V.A.C.® THERAPY SYSTEM WILL NOT BE EFFECTIVE IN ADDRESSING COMPLICATIONS ASSOCIATED WITH THE FOLLOWING: -ISCHEMIA TO THE INCISION OR INCISION AREA. -UNTREATED OR INADEQUATELY TREATED INFECTION. -INADEQUATE HEMOSTASIS OF THE INCISION. DISCLAIMER: THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A KINETIC CONCEPTS, INC. PRODUCT MALFUNCTIONED, IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

Description of Event or Problem · 0

ON (B)(6) 2022, THE PATIENT'S LEGAL REPRESENTATIVE MADE THE FOLLOWING ALLEGATIONS IN A LETTER SENT TO KCI: "IN THE COURSE OF THE SURGERY PERFORMED ON (B)(6) 2021, A "WOUND VAC" WAS ATTACHED TO THE SURGICAL SITE. PART OF THE WOUND VAC SYSTEM WAS A BLACK SPONGE THAT WAS IMPLANTED INTERNALLY. THIS SPONGE WAS LEFT IN THE PATIENT'S BODY AFTER THE WOUND VAC WAS DISCONTINUED. DURING THIS TIME, SOME CARE WAS BEING PROVIDED BY KCI USA, INC, TOGETHER WITH OTHERS. THEREFORE, KCI USA, INC., WAS NEGLIGENT IN FAILING TO PROPERLY EVALUATE THE PATIENT'S CONDITION AND REMOVE THE SPONGE, OR ALTERNATIVELY, ALERT HER OTHER HEALTH CARE PROVIDERS TO HAVE THE SPONGE REMOVED. AS A RESULT OF HAVING THE SPONGE IN HER BACK FOR MORE THAN A YEAR, THE PATIENT NOW HAS OSTEOMYELITIS OF THE SPINE, A VERY SERIOUS MEDICAL CONDITION." ON (B)(6) 2022, THE FOLLOWING INFORMATION WAS OBTAINED AFTER REVIEW OF MEDICAL RECORDS: ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR PERSISTENT POSTOPERATIVE EPIDURAL FLUID COLLECTION FROM A PRIOR DECOMPRESSIVE LAMINECTOMY AND POLAR FUSION ON (B)(6) 2020. THE PATIENT HAS HAD LONGSTANDING PROBLEMS WITH HER BACK. AN ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING DEVICE WAS PLACED. THE PATIENT WAS ORDERED TO HAVE HOME HEALTH THREE TIMES WEEKLY TO CHANGE HER DRESSINGS. THE PATIENT'S WOUND IMPROVED AND V.A.C.® THERAPY WAS DISCONTINUED ON (B)(6) 2021. ON (B)(6) 2022, THE PATIENT COMPLAINED OF LEFT THIGH PAIN AND PRESENTED TO THE EMERGENCY ROOM WHERE A COMPUTERIZED TOMOGRAPHY (CT) SCAN INDICATED SOFT TISSUE INFLAMMATION AND POSSIBLE OSTEOMYELITIS AT L4-5 VERTEBRAE OF THE LUMBAR SPINE AND WHAT APPEARED TO BE A FLUID FILLED SAC IN THE DURA. DURING SURGERY, APPROXIMATELY 4.5 INCHES OF FOREIGN MATERIAL ALLEGED TO BE V.A.C.® GRANUFOAM¿ DRESSING WAS SURGICALLY REMOVED FROM THE TOP OF THE DURA AND CULTURED. ONCE REMOVED, THE PATIENT WAS PLACED ON THE V.A.C.ULTA¿ THERAPY SYSTEM UNTIL PLACEMENT OF AN ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING DEVICE. DURING A DRESSING CHANGE ON (B)(6) 2022, IT WAS REPORTED BY THE NURSE THAT THE PATIENT STATED SHE HAD MANY MISSED VISITS WITH THE HOME HEALTH AND HER BOYFRIEND WOULD CHANGE HER DRESSINGS, WHICH WAS AGAINST PHYSICIAN'S ORDERS. IT WAS NOTED THAT IT WAS POSSIBLE THE BOYFRIEND COULD HAVE LEFT THE FOAM AND THAT NURSES WERE UNABLE TO SEE IF THE WOUND HAD CLOSED OVER IT. THE NURSE WAS CONCERNED WITH THE PATIENT'S NON-COMPLIANCE. ON (B)(6) 2022, THE PATIENT CONTINUES WITH V.A.C.® THERAPY WITH A DIFFERENT HOME HEALTH AGENCY. THE PATIENT IS ON INTRAVENOUS VANCOMYCIN. HOSPITAL AND HOME HEALTH INFORMATION REPORT SHE IS NON-COMPLAINT WITH SHOWING UP FOR APPOINTMENTS OR REFUSES HOME HEALTH VISITS. SHE HAS LET HER BOYFRIEND CHANGE HER WOUND V.A.C.® DRESSING RECENTLY. THERAPY WAS DISCONTINUED ON (B)(6) 2022 AS GOAL OF THERAPY MET. THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER WAS NOT PROVIDED, AND THE PRODUCT WAS NOT RETURNED; THEREFORE, A DEVICE HISTORY RECORD REVIEW AND DEVICE EVALUATION COULD NOT BE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2385188	V.A.C.® GRANUFOAM¿ DRESSING	OMP	OMP	KINETIC CONCEPTS, INC.	VACDSP	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR	Female	Required Intervention\| H