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 Corporation.
[185521034]
Patient was receiving a tacrolimus infusion. The bag was spiked to administer the medication when the tubing was noted to be leaking. New tubing was received, and the infusion was completed. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897344 |
| MDR Report Key | 9897344 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-23 |
| Date of Event | 2020-03-12 |
| 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 CORPORATION |
| Manufacturer Address | 25212 W. ILLINOIS ROUTE 120 ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |