MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP160 manufactured by Edwards Lifesciences Dr.
[114676711]
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. No corrective actions will be taken at this time. Lot number was not provided; therefore review of the manufacturing records could not be completed. 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. It is unknown whether user or procedural factors played a role in this 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
[114676712]
It was reported that during use, the pressure tubing detached which caused an arterial hemorrhage and approximately 200 ml of blood loss. There was no need for a transfusion. No other patient complications reported. The device was discarded at the hospital. Patient demographics were unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-02850 |
| MDR Report Key | 7691972 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-06-22 |
| Date Mfgr Received | 2018-06-26 |
| Date Added to Maude | 2018-07-16 |
| 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 | PHARMACIST |
| 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 | CARR. SANCHEZ KM 18.5 |
| 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 | 2018-07-16 |
| Model Number | 48VMP160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-07-16 |