MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-05-16 for VACUUM RELIEF VALVE IIC-CLEAR 4004103 * manufactured by Quest Medical, Inc..
[485229]
While giving cardioplegia, the surgeon noticed that the heart was not stopping. The surgeon requested increased cardioplegia and then noticed blood on floor. The perfusionist checked the circuit and noted blood around valve. The valve was replaced and no further incidents were repoated. The product was saved and will be returned. Product code 400103, lot number is either 25259. C11 or 25775. E09
Patient Sequence No: 1, Text Type: D, B5
[7843524]
Additional lot# 25775. E09, additional exp date: 01/30/2009.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2006-00047 |
| MDR Report Key | 717926 |
| Report Source | 06 |
| Date Received | 2006-05-16 |
| Date of Report | 2006-05-05 |
| Date of Event | 2006-04-28 |
| Date Mfgr Received | 2006-04-28 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2006-05-25 |
| 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 | 0 |
| Manufacturer Contact | KATHRYN JAYNE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723909800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VACUUM RELIEF VALVE IIC-CLEAR |
| Generic Name | VACUUM RELIEF VALVE |
| Product Code | MNJ |
| Date Received | 2006-05-16 |
| Returned To Mfg | 2006-05-05 |
| Model Number | 4004103 |
| Catalog Number | * |
| Lot Number | 25259.C11 |
| ID Number | * |
| Device Expiration Date | 2008-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 707001 |
| Manufacturer | QUEST MEDICAL, INC. |
| Manufacturer Address | ONE ALLENTOWN PKWY. ALLEN TX 75002 US |
| Baseline Brand Name | VACUM RELIEF VALVE IIC-CLEAR |
| Baseline Generic Name | VACUM RELIEF VALVE |
| Baseline Model No | 4004103 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-16 |