MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-04-06 for RLV-2100 B VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..
[41995035]
There is no sample available for evaluation. The original report included a video of the device in use; however, it provided only a limited view of the tubes and extension lines. From that view, the manufacturer attempted to capture every possible scenario that could result in the reported type of leakage. The purpose of the suction control device is to prevent excessive negative pressures in the ventricle. The product also contains an anti-backflow feature to prevent retrograde flow and a pressure relief valve that vents blood purposely to atmosphere in the event retrograde flow due to operator or installation error. During operation, the product operates under vacuum. Any leak path will result air flow from the atmosphere into the conduit. When flow is near or at zero flow, a slight positive pressure may result and cause blood to leak onto the floor. These valves are designed for pressure relief at a negative pressure of -200mmhg and at a positive pressure <1300mmhg, any time negative or positive pressure exceed these specifications the valve leaks. Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[41995036]
The foreign distributor ((b)(4)) reported an issue encountered by their customer while using the suction control device. This device was sold to the distributor as sterile, bulk shipment for further processing for their customers. The distributor could not determine the exact lot number affected but was able to identify 3 possible lots. The device was discarded by the user and not returned to the distributor or manufacturer for analysis. There was no additional information to be obtained other than the original report. The report had stated that the suction control device had leaked during use, near the end of the procedure. The reported blood loss was approximated to be 50 cc. There were no patient complications reported as a result of the alleged event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2016-00012 |
| MDR Report Key | 5551105 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2016-04-06 |
| Date of Report | 2016-03-11 |
| Date of Event | 2016-03-11 |
| Date Mfgr Received | 2016-03-11 |
| Date Added to Maude | 2016-04-06 |
| 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. AMY CLENDENING-WHEELER |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RLV-2100 B VACUUM RELIEF VALVE |
| Generic Name | CARDIOVASCULAR SUCTION CONTROL VALVE |
| Product Code | DWD |
| Date Received | 2016-04-06 |
| Model Number | 4103202 |
| Lot Number | 047264, 047470, OR 047578 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-06 |