MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-26 for VAMP JR. KIT PXVJ050M manufactured by Edwards Lifesciences Dr.
[126542566]
One single dpt - vamp jr. Kit was returned for examination. The reported event of broken tubing from the reservoir was confirmed. The pressure tubing was found broken from the bond joint that connects with the vamp jr. Reservoir. The cross surfaces of the broken tubing appeared uneven. No other damage was observed from the kit. 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. 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. Tubing breakage will most likely occur during handling and manipulation of the product and will result in an obvious leak prior to connecting to the patient or during tightening of connections during use. Therefore, the break in the system will be immediately detected. 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, the break was found before use and there was no patient involvement. 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
[126542567]
It was reported that before use, the tubing of the disposable pressure transducer with vamp disconnected from the vamp jr reservoir. The device was replaced and worked successfully. There was no allegation of patient injury. The device was available for evaluation. Patient demographics were requested, but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-04401 |
| MDR Report Key | 8010247 |
| Date Received | 2018-10-26 |
| Date of Report | 2018-08-16 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-10-30 |
| Device Manufacturer Date | 2018-01-20 |
| Date Added to Maude | 2018-10-26 |
| 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 | 0 |
| Brand Name | VAMP JR. KIT |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2018-10-26 |
| Returned To Mfg | 2018-10-01 |
| Model Number | PXVJ050M |
| Lot Number | 61202083 |
| 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 | 2018-10-26 |