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 2017-11-15 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP172 manufactured by Edwards Lifesciences Dr.
[92907777]
We received one vamp adult system for examination. The reported event of "pressure line in this vamp adult system got disconnected" was confirmed. The tubing had detached from the bond joint with the vamp adult reservoir. The tubing was bent near the point of detachment. Indications of bonding material were evident on some locations of the tubing bond surface area. The tubing outer diameter was found to be within specification. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint. A review of the manufacturing records indicated that the product met specifications upon release. It is common clinical practice to inspect all products before usage. These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use. If the pressure tubing becomes detached during use, it will affect the pressure waveform, which will immediately alert the clinician to begin the troubleshooting process. Invasive procedures involve some patient risks. Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the possible complications. There is potential that user factors may have contributed to the event. 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.
Patient Sequence No: 1, Text Type: N, H10
[92907778]
It was reported that as the patient was being repositioned, the pressure line in this vamp adult system disconnected. The clinician commented that "there was too much traction on the pressure line during the repositioning". It was noticed immediately and the patient had no blood loss. The customer opened a new kit from the same lot number, checked the connections and replaced the device with no further issues. There was no injury to the patient. The device was available for evaluation. Inquired of patient demographics. Unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2017-03852 |
| MDR Report Key | 7035004 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-15 |
| Date of Report | 2017-10-25 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2017-10-25 |
| Device Manufacturer Date | 2017-05-10 |
| Date Added to Maude | 2017-11-15 |
| 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 | MS SAMANTHA EVELEIGH |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| 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 | 2017-11-15 |
| Returned To Mfg | 2017-11-03 |
| Model Number | 48VMP172 |
| Lot Number | 60871678 |
| Device Expiration Date | 2019-05-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-11-15 |