MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for MPS DELIVERY SET 5001102 manufactured by Quest Medical, Inc..
[146360794]
The alleged incident took place in (b)(6). This medwatch is being submitted because quest distributes a similar device in the us. The device will be evaluated when it is received from the customer and a follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[146360795]
A report was received regarding an alleged issue encountered during use of the mps delivery set. The report states that while priming the mps gave an inadequate inlet pressure message. It was cleared and the mps primed with no issues. While the pump was recirculating the user tried flushing the cardioplegia line to the table. The same alarm was seen and the alarm could not be cleared and the console would not flow forward. The console was changed out before going on bypass and the prime line was flushed to the sterile field. While flushing cardioplegia to the field, the same error message was seen and the user could not get forward flow. The inflow line to the mps was switched to the recirc line with a 1/4x1/4 connector but this did not resolve the error message. The disposable was thereafter changed and this resolved the alarm. There were no patient complications resulting from the alleged incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00026 |
| MDR Report Key | 8597384 |
| Date Received | 2019-05-09 |
| Date of Report | 2019-08-22 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-09 |
| 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 | 2019-05-09 |
| Returned To Mfg | 2019-05-09 |
| Model Number | 5001102 |
| Lot Number | 0575809F05 |
| 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 | 2019-05-09 |