MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-04-24 for MPS DELIVERY SET 5001100 manufactured by Quest Medical, Inc..
[142938035]
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
[142938036]
A report was received regarding an alleged issue encountered during use of the mps delivery set. The report states that while giving the first and only dose of cardioplegia the right sided k+ port started to leak. The perfusionist was able to get the full dose in. The delivery set was changed out but additional dose was not needed following the change. There were no reported patient complications resulting from the alleged incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2019-00023 |
| MDR Report Key | 8545212 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-04-24 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-03-28 |
| 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 | 3 |
| Brand Name | MPS DELIVERY SET |
| Generic Name | CPBP HEAT EXCHANGER |
| Product Code | DTR |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-05-01 |
| Model Number | 5001100 |
| Catalog Number | 5001100 |
| Lot Number | 0568758C09 |
| 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 |