VASOVIEW HEMOPRO
Report
- Report Number
- 2242352-2023-00388
- Event Type
- Malfunction
- Date Received
- May 16, 2023
- Date of Event
- April 21, 2023
- Report Date
- October 18, 2023
- Manufacturer
- MAQUET CARDIOVASCULAR LLC
- Product Code
- GEI
- UDI-DI
- 00607567701250
- PMA / PMN Number
- K153194
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
TRACKWISE#: (B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/02/2023. AN INVESTIGATION WAS CONDUCTED ON 05/10/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE CANNULA WAS NOT RETURNED FOR EVALUATION, HOWEVER THE BTT WAS RETURNED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. THE BTT WAS ABLE TO BE INFLATED. THE INSUFFLATION PORT WAS OBSERVED TO BE DETACHED FROM THE BTT. THE DETACHED PORT WAS NOT RETURNED FOR EVALUATION. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "BREAK; CANNULA; TUBE" WAS NOT CONFIRMED, HOWEVER, THE ANALYZED FAILURE "BREAK; BTT" WAS OBSERVED. AN ENGINEER EVALUATION WAS CONDUCTED. AFTER INSPECTION OF THE DEVICE, IT WAS IDENTIFIED THAT THERE WAS VISIBLY EITHER VERY LITTLE OR NO ADHESIVE ON THE INSUFFLATION TUBING/BTT PORT. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "BREAK; CANNULA; TUBE" WAS NOT CONFIRMED, HOWEVER, THE ANALYZED FAILURE "BREAK; BTT" WAS OBSERVED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. SPECIFIC ACTIONS FOR THE REPORTED FAILURE MODE ARE BEING MAINTAINED AND DOCUMENTED UNDER MAQUET'S CORRECTIVE AND PREVENTIVE ACTION (CAPA) SYSTEM.
TRACKWISE#:(B)(4). THE DEVICE WAS RETURNED TO THE FACTORY FOR EVALUATION ON 05/02/2023. AN INVESTIGATION WAS CONDUCTED ON 05/10/2023. A VISUAL INSPECTION WAS CONDUCTED. SIGNS OF CLINICAL USE AND EVIDENCE OF BLOOD WAS OBSERVED. THE CANNULA WAS NOT RETURNED FOR EVALUATION, HOWEVER THE BTT WAS RETURNED. THERE WERE NO VISUAL DEFECTS OBSERVED ON THE INTACT BTT. THE BTT WAS ABLE TO BE INFLATED. THE INSUFFLATION PORT WAS OBSERVED TO BE DETACHED FROM THE BTT. THE DETACHED PORT WAS NOT RETURNED FOR EVALUATION. BASED ON THE RETURNED CONDITION OF THE DEVICE AS WELL AS THE EVALUATION RESULTS, THE REPORTED FAILURE "BREAK; CANNULA; TUBE" WAS NOT CONFIRMED, HOWEVER, THE ANALYZED FAILURE "BREAK; BTT" WAS OBSERVED. THE DHR, SHOP FLOOR PAPERWORK WAS REVIEWED. THE VENDOR CERTIFIES THAT THIS DEVICE SERIAL/LOT CONFORMS TO ALL APPLICABLE PRODUCT SPECIFICATIONS. THE LOT # 3000293522 HISTORY RECORD REVIEW WAS COMPLETED. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE BATCH MANUFACTURING PROCESS AND THE REPORTED FAILURE.
TRACKWISE ID (B)(6). THE DEVICE HAS BEEN RETURNED TO THE FACTORY AND IS BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETED.
N/A.
N/A.
THE HOSPITAL REPORTED THAT BEFORE THE PATIENT WAS IN THE ROOM FOR THE ENDOSCOPIC VEIN HARVESTING PROCEDURE, THE VASOVIEW HEMOPRO (US) VH-3500 TUBING FROM THE CANNULA BROKE OFF BEFORE IT COULD BE USED. THERE WAS A SLIGHT DELAY TO THE HARVESTING BUT NOT THE HEART SURGERY. ANOTHER DEVICE WAS OPENED AND USED. NO PATIENT HARM REPORTED, AS THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1637928 | VASOVIEW HEMOPRO | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | GEI | MAQUET CARDIOVASCULAR LLC | VH-3500 | 3000293522 | 00607567701250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Prefer Not To Disclose | N/A. |