MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-22 for VAMP UNKNOWN VAMPUNKNOWN manufactured by Edwards Lifesciences Dr.
[109007628]
The device was not returned for evaluation as 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 user or 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. Invasive procedures involve some form of patient risk. Although serious complications are relatively uncommon, the physician is advised to consider the potential benefits in relation to the potential complications. An incorrect flow rate on a dpt can result in significant unintended fluid delivery which can pose a risk to the patient. As previously stated, it is unknown at this time whether an adult or pediatric dpt was being used and if a pediatric dpt, whether the system was on a pump. Use of a pump on a pediatric dpt system can prevent incorrect flow rate from occurring. An edwards representative met with a clinical nurse specialist and nurse educator after the event and an in-servicing was performed. 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
[109007629]
It was reported 500mls of normal saline was infused into a (b)(6) patient when using the vamp jr and disposable pressure transducer (dpt) system. The fluid was infused over a 4-hour time frame. The dpt system was on a pressure bag set-up using 300mmhg. It is unknown at this time whether an adult or pediatric dpt was being used and if a pediatric dpt, whether the system was on a pump. There was no patient injury reported. The device was discarded at the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-01947 |
| MDR Report Key | 7535475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-22 |
| Date of Report | 2018-04-29 |
| Date of Event | 2018-04-29 |
| Date Mfgr Received | 2018-04-29 |
| Date Added to Maude | 2018-05-22 |
| 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 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 UNKNOWN |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2018-05-22 |
| Model Number | VAMPUNKNOWN |
| 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 | 2018-05-22 |