MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP160 manufactured by Edwards Lifesciences Dr.
[143435299]
One vamp adult system was returned for examination. The reported event of? Saline leakage was observed between the one way stopcock and the vamp? Was confirmed. As received, the tubing had detached from the bond joint with a vamp adult reservoir stopcock. The tubing was bent near the point of detachment. Indications of bonding solvent were evident on the tubing bond surface area. The tubing outer diameter was measured near the point of detachment and was found to be within specification. A review of the manufacturing records indicated that the product met specifications upon release. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions. 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. In addition, they are used in critical care units or ors where patients are closely monitored. 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. In this event, there was no compromise noted. 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 a part of the monthly review.
Patient Sequence No: 1, Text Type: N, H10
[143435300]
It was reported that before use in this vamp adult system, saline leakage was observed between the one way stopcock and the vamp. A new kit was used to resolve the issue. There was no allegation of patient injury. The vamp system was available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01422 |
| MDR Report Key | 8541676 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-02-26 |
| Date of Event | 2019-02-26 |
| Date Mfgr Received | 2019-05-31 |
| Device Manufacturer Date | 2018-03-28 |
| Date Added to Maude | 2019-04-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS LYNN THOMAS |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| 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 | 0 |
| Brand Name | VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2019-04-23 |
| Returned To Mfg | 2019-03-29 |
| Model Number | 48VMP160 |
| Lot Number | 61308015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-04-23 |