MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-25 for VAMP JR. VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM VMP448PX manufactured by Edwards Lifesciences Dr.
[137529520]
The device was not returned for evaluation. 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 procedural factors may have contributed to the event. A supplemental report will be forthcoming when the device history record is completed. 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 common clinical practice to inspect all products before use. These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use. In addition, these devices are typically used in intensive care units or operating rooms, where patients are closely monitored. Since these devices are indicated for pediatric patients, whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults. Consequently, there is potential for patient injury. In this case, there were no patient complications 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 part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[137529521]
It was reported that during use with a vamp junior kit a blood gas sample was drawn. While withdrawing the syringe with the access cannula, the z-site septum disk dislodged. This caused blood to come out of the z-site septum. The amount of blood loss is unknown at this time. There was no allegation of patient injury. The device was discarded due to contamination. Patient demographics were unable to be obtained. Any additional information will be submitted in a supplemental report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-00635 |
| MDR Report Key | 8366598 |
| Date Received | 2019-02-25 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-04-05 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2019-02-25 |
| 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 | MRS 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 HAINA, SAN CRISTOBAL |
| 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 JR. VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2019-02-25 |
| Model Number | VMP448PX |
| Lot Number | 61111893 OR 61314532 |
| 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 HAINA, SAN CRISTOBAL CARR. SANCHEZ KM 18.5 DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-25 |