MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for CUSTOM TUBING PACK BB7V76R CUSTOM PACK manufactured by Medtronic, Inc..
[183909489]
Connection loose and dislodged. Air entered circuit. Cpr done for 7 minutes while air removed. Peds small tubing pack - on the venous side of the circuit, second stopcock/pigtail set up connected to the cdi. The phlange/leur lock on the stopcock connected to this pigtail loosened and air was entering into the circuit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9847306 |
| MDR Report Key | 9847306 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-31 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-18 |
| Date Added to Maude | 2020-03-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM TUBING PACK |
| Generic Name | TUBING, PUMP, CARDIOPULMONARY BYPASS |
| Product Code | DWE |
| Date Received | 2020-03-18 |
| Model Number | BB7V76R |
| Catalog Number | CUSTOM PACK |
| Lot Number | 217707126 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC, INC. |
| Manufacturer Address | 710 MEDTRONIC PKWY MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |