MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-11-14 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..
[59835818]
There are no more devices of the same lot remaining in inventory for evaluation. 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
[59835819]
The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device. The report stated the device was part of a "sucker line", a negative pressure line used during an ecmo procedure. The report stated that the one-way valve was stuck open, and to resolve the issue a cap was placed on the negative pressure release and another valve was placed proximal to the open valve. The report stated that blood was lost that required a blood transfusion to the patient and an acute pressure drop was observed as a result of the alleged event. The report was completed and no further patient impact was reported. The device was discarded by the end-user and not returned to the distributor or manufacturer for evaluation. The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.
Patient Sequence No: 1, Text Type: D, B5
[62401064]
The device was not returned to the manufacturer for evaluation. There were no more devices of the same lot remaining in inventory for evaluation. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00055 |
| MDR Report Key | 6100637 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-11-14 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-10-17 |
| Date Mfgr Received | 2016-10-18 |
| Device Manufacturer Date | 2016-01-26 |
| Date Added to Maude | 2016-11-14 |
| 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 VACUUM RELIEF VALVE |
| Generic Name | CARDIOPULMONARY SUCTION CONTROL DEVICE |
| Product Code | DWD |
| Date Received | 2016-11-14 |
| Model Number | 4103202 |
| Lot Number | 050562 |
| Device Availability | N |
| Device Age | DA |
| 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 | 2016-11-14 |