MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-25 for RLV 2100-B SUCTION CONTROL DEVICE 4103102 manufactured by Quest Medical, Inc..
[32135584]
There were no other devices remaining in inventory for analysis. The device samples returned for evaluation passed all functional and performance testing. The complaint could not be confirmed. The purpose of the valve is to prevent excessive negative pressure in the ventricle. It contains an anti-backflow feature to prevent retrograde flow, and a pressure relief valve that vents blood in the event of retrograde flow due to operator or installation error. 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
[32135585]
The hospital sterile processor reported for the perfusionist that there was an issue encountered while using the suction control devices. The report stated that both suction valves leaked during the procedure. Follow up with the complainant found that the volume of blood loss was not recorded. The valves were changed out and the procedure was successfully completed. There were no patient complications reported as a result of the alleged event. The valves were returned to the manufacturer for analysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2015-00101 |
| MDR Report Key | 5250312 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-25 |
| Date of Report | 2015-10-28 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2015-10-28 |
| Device Manufacturer Date | 2015-01-29 |
| Date Added to Maude | 2015-11-25 |
| 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. 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 SUCTION CONTROL DEVICE |
| Generic Name | SUCTION CONTROL VALVE |
| Product Code | DWD |
| Date Received | 2015-11-25 |
| Returned To Mfg | 2015-11-03 |
| Model Number | 4103102 |
| Lot Number | 0483215J07 |
| Device Expiration Date | 2018-01-20 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-11-25 |