ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
Report
- Report Number
- 3009897021-2021-00168
- Event Type
- Injury
- Date Received
- July 14, 2021
- Date of Event
- June 13, 2021
- Report Date
- October 1, 2021
- Manufacturer
- KINETIC CONCEPTS, INC.
- Product Code
- OMP
- UDI-DI
- 00849554005600
- PMA / PMN Number
- K201571
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
MDR-3009897021-2021-00168 SUBMITTED ON (B)(6) 2021 NOTED THE FOLLOWING: SECTION G4 PMA/510(K): K133276 CORRECTION: SECTION G4 PMA/510(K): K201571 ADDITIONAL INFORMATION FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 8836884V007: D4 EXPIRATION DATE: (B)(6) 2023. H4 DEVICE MANUFACTURE DATE: (B)(6) 2020. BASED ON THE CORRECTION AND ADDITIONAL INFORMATION REGARDING THE V.A.C.® GRANUFOAM¿ DRESSING, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM.
BASED ON THE ADDITIONAL INFORMATION PROVIDED REGARDING THE DEVICE, KCI'S ASSESSMENT REMAINS THE SAME; IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. THE DEVICE PASSED QUALITY CONTROL CHECKS BEFORE PATIENT PLACEMENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.
ON (B)(6)2021, A DEVICE HISTORY RECORD REVIEW FOR V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 8836884V007 WAS COMPLETED. ALL END RELEASE TESTING OF THE PRODUCT AND PACKAGING MET SPECIFICATIONS. ON (B)(6)2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6)2021, THE DEVICE WAS PLACED WITH THE PATIENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE, THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.
ON (B)(6) 2021, A DEVICE EVALUATION WAS COMPLETED BY QUALITY ENGINEERING. ON (B)(6) 2021, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI SERVICE CENTER AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2021, THE DEVICE WAS PLACED WITH THE PATIENT. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED.
BASED ON INFORMATION PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED INFECTION IS RELATED TO THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM. KCI HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION. A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING AND A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS PENDING. DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES: 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. CELLULITIS OF THE INCISION AREA.
ON 17-JUN-2021, THE FOLLOWING INFORMATION WAS REPORTED TO KCI BY THE PATIENT'S DAUGHTER: ON (B)(6) 2021, THE PATIENT FELL AND WAS ADMITTED TO THE HOSPITAL DUE TO AN ALLEGED INFECTION. THE PATIENT WILL BE TRANSFERRED TO ANOTHER HOSPITAL AND WILL POSSIBLY BE GOING TO A NURSING HOME. THE PATIENT HAD BEEN ON ANTIBIOTICS BUT DATES WERE NOT KNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. A DEVICE HISTORY RECORD REVIEW FOR THE V.A.C.® GRANUFOAM¿ DRESSING LOT NUMBER 8836884V007 IS CURRENTLY PENDING COMPLETION. A DEVICE EVALUATION OF THE ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM IS CURRENTLY PENDING COMPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1065934 | ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM | OMP | OMP | KINETIC CONCEPTS, INC. | WNDARM | 8836884V007 | 00849554005600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Hospitalization| R | ELIQUIS 5 MG| HYDROCODONE 325 MG| LEXAPRO 10 MG| LIPITOR 10 MG| LYRICA 25 MG| METFORMIN 500MG| PRINIVIL 20 MG| TIAZAC 240 MG| TYLENOL 325 MG| ULTRAM 50 MG| ELIQUIS 5 MG| HYDROCODONE 325 MG| LEXAPRO 10 MG| LIPITOR 10 MG| LYRICA 25 MG| METFORMIN 500MG| PRINIVIL 20 MG| TIAZAC 240 MG| TYLENOL 325 MG| ULTRAM 50 MG |