MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-17 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP160 manufactured by Edwards Lifesciences Dr.
[72992080]
The device was not returned for evaluation; it was discarded at the hospital. Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event. It is not known if some procedural factors may have contributed to the event. No corrective actions will be taken at this time. Lot number was not provided; therefore review of the manufacturing records could not be completed. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. Detached tubing will most likely occur during manipulation of the product by the clinician. Because the clinician is present, the stopcock can be used to stop the flow of blood, preventing blood loss. The system can be exchanged easily for another one, causing a minor delay in treatment or monitoring.
Patient Sequence No: 1, Text Type: N, H10
[72992081]
As reported, the tubing of this vamp system disconnected, causing blood loss. The issue was solved by exchanging the device for a new one. There was no allegation of patient injury. It is not known if the patient had been transferred or moved, and it was not possible to quantify the blood loss. Inquired of patient demographics from the reporter, unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5
[74548838]
Model and 510k was updated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2017-01033 |
| MDR Report Key | 6498935 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-17 |
| Date of Report | 2017-03-09 |
| Date of Event | 2016-12-17 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-04-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR BRIAN HURD-SERVIN |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492506423 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2017-04-17 |
| Model Number | 48VMP160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-17 |