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 2018-09-18 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP160 manufactured by Edwards Lifesciences Dr.
[120693053]
The device was not returned for evaluation as it was discarded at the hospital. Without return of the product, 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. In this event there was a detachment of tubing at the housing of the stopcock which led to blood loss, decrease in hemoglobin and the need for 3 packed red blood cells to be transfused. The patient alerted the clinician that there was blood leakage. The potential for injury is not remote in this instance, as the clinician was not present and was not alerted to the blood loss by receiving an abnormal waveform/alarm. These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise. 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 a part of the monthly review.
Patient Sequence No: 1, Text Type: N, H10
[120693054]
It was reported that during use with a (b)(6) year old male patient, the tubing of the disposable pressure transducer with vamp disconnected from the housing at the stopcock. The patient alerted the staff, who had to clamp the tubing. The patient lost 1g/dl of hemoglobin; it is unknown how much in terms of volume. The patient was transfused with 3 units of packed red blood cells (prbc). No further information as to comorbidities has been obtained to date. Unfortunately, the product was not available for evaluation since it was discarded.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-03835 |
| MDR Report Key | 7886243 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-18 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-08-29 |
| Date Mfgr Received | 2018-08-30 |
| Date Added to Maude | 2018-09-18 |
| 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 | MS LYNN SELAWSKI |
| 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 | 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 | 2018-09-18 |
| 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 | 1. Required No Informationntervention | 2018-09-18 |