MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-18 for 3/8 X 3/8 X 3/8 Y 6031 manufactured by Medtronic Mexico.
[166738579]
The event date entered is month and year valid. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[166738580]
Medtronic received information that about 20:00 hrs during the extra corporeal membrane oxygenation (ecmo) procedure, the customer reported leaking from around the y-connector that connected the lv vent to the venous drainage line on the ecmo circuit. The customer was concerned that the leak was either due to a loose connection or that one of the lines was fractured. Following notification to the perfusionist, md and surgeon, they intended to fix the issue using a zip tie and bone wax. However, around 21:00 hrs, the y-connector the broke and the patient began to exsanguinate. Flows were lost and cpr was initiated. They then clamped the ecmo cannula, mass transfusion protocol was initiated, patient was intubated and a line was placed. They were able to replace the y-connector and re-establish flow.
Patient Sequence No: 1, Text Type: D, B5
[181860913]
Visual analysis: visual inspection shows one of the 3/8 inch tubing connections has broken off. Device was cleaned using a 10% bleach solution. Conclusion; based on the investigation results it can be concluded that there is not enough evidence to say that the damage was cause during the manufacturing process since the handling of the connector performed during the inspection and packaging does not required to apply force that could damage the ports of the connector. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612164-2019-04774 |
| MDR Report Key | 9334255 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-18 |
| Date of Report | 2019-11-18 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2019-11-07 |
| Device Manufacturer Date | 2018-09-19 |
| Date Added to Maude | 2019-11-18 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC MEXICO |
| Manufacturer Street | AV. PASEO DEL CUCAPAH #10510 |
| Manufacturer City | TIJUANA,BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3/8 X 3/8 X 3/8 Y |
| Generic Name | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Product Code | DWE |
| Date Received | 2019-11-18 |
| Model Number | 6031 |
| Catalog Number | 6031 |
| Lot Number | 216211872 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC MEXICO |
| Manufacturer Address | AV. PASEO DEL CUCAPAH #10510 TIJUANA,BC 22570 MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-18 |