MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for CLEARLINK/DUO-VENT 2C8875 manufactured by Baxter Healthcare Corporaton.
[185521027]
Tacrolimus medication bag was spiked and primed when the rn noticed the tacrolimus began to drip out beneath the lower filter on the iv tubing line. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897366 |
| MDR Report Key | 9897366 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-17 |
| Report Date | 2020-03-23 |
| Date Reported to FDA | 2020-03-23 |
| Date Reported to Mfgr | 2020-03-30 |
| Date Added to Maude | 2020-03-30 |
| 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 | RISK MANAGER |
| 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 | CLEARLINK/DUO-VENT |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| Model Number | 2C8875 |
| Catalog Number | 2C8875 |
| Lot Number | R19H30025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATON |
| Manufacturer Address | 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |