MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for MPS DELIVERY SET 5001102 manufactured by Quest Medical, Inc..
[146360769]
The device will be evaluated and a follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[146360770]
A report was received regarding an alleged issue encountered during use of the mps delivery set. The report states that during a case, the mps displayed inadequate fill. Arterial flow was high but clamp would not open. The console was changed out and they used the same disposable without further issues but when they tried to give cardioplegia, the mps would not deliver. They took the cross clamp off, changed the disposable, gave cardioplegia and the case proceeded without further issues. There were no reported patient complications resulting from the alleged incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00024 |
| MDR Report Key | 8545215 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-04-04 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-04-24 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TOSAN ONOSODE |
| 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 | 0 |
| Brand Name | MPS DELIVERY SET |
| Generic Name | CPBP HEAT EXCHANGER |
| Product Code | DTR |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-04-22 |
| Model Number | 5001102 |
| Lot Number | 0576899F10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2019-04-24 |