MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-05 for VAMP VENOUS ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM WITH ARM MOUNT RESERVOIR 48VMP120 manufactured by Edwards Lifesciences Dr.
[113642779]
One vamp adult system with a 10cc b-d syringe was returned for examination. The reported event of "leaking" was confirmed. Leakage was detected at the bond joint between the pressure tubing to the reservoir stopcock. Red dye solution was manually injected into the vamp system to trace the leak path. Leakage was found occurring across the bond area. No visible damage or defect was observed from pressure tubing and reservoir stopcock. The tubing outer diameter near the point of detachment was measured and found to be within specification. 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. Leakage implies a small amount of blood/fluid loss. This device was used for monitoring pediatric arterial blood pressure and blood sampling. Since this device was used on a pediatric patient whose blood volume is much smaller than an adult, they cannot tolerate blood loss as easily as adults. A leak in the system may cause a dampened waveform to be displayed on the patient monitor, thereby alerting the clinician to start the troubleshooting process. Additionally, these products are used by highly trained clinicians, experienced in identifying 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. 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. Udi number- (b)(4). Hospital number (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113642780]
It was reported that a (b)(6) year old male with acute respiratory failure was treated with an adult arterial line sampling manifold that was connected to an ecmo circuit. The nurse observed a leak through a crack and changed out the device for a new one. No patient complications reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-02643 |
| MDR Report Key | 7665678 |
| Date Received | 2018-07-05 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-04-19 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2017-01-25 |
| Date Added to Maude | 2018-07-05 |
| 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 | RISK MANAGER |
| 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 | HAINA, SAN CRISTOBAL |
| 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 | 2018-07-05 |
| Returned To Mfg | 2018-07-02 |
| Model Number | 48VMP120 |
| Lot Number | 60719466 |
| Device Expiration Date | 2019-01-25 |
| 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 | 2018-07-05 |