MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for CLEARLINK NON-DEHP SOLUTION SET 2H8486 manufactured by Baxter Healthcare Corporation.
[185517631]
Lipid tubing would not prime once the lipids reached the filter. Multiple attempts to push lipids through were attempted including: clamping and unclamping, squeezing the bag, untwisting the end cap, using a syringe at the distal port to suck out and push the lipids through but did not work. We also tried lowering it down as far as possible to let gravity work. Another set of tubing was obtained and same thing happened. In the end, i clamped with the roller clamp, hooked up a flush to the port below the roller clamp and flushed through. Then let unclamped and let the lipids run through. It seemed like they got stuck again, but i figured the iv pump would be able to pull it out now that the line was actually primed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9897123 |
| MDR Report Key | 9897123 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-03-12 |
| Report Date | 2020-03-25 |
| Date Reported to FDA | 2020-03-25 |
| 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 | 0 |
| 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 | CLEARLINK NON-DEHP SOLUTION SET |
| Generic Name | SET, ADMINISTRATION, INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-30 |
| Model Number | 2H8486 |
| Catalog Number | 2H8486 |
| Lot Number | R18G05079 |
| 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 |