MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for CLEARLINK 2C8750 manufactured by Baxter International Inc..
[177779030]
After 5 minutes of platelets infusing, tubing noted to be leaking at the distal end of the tubing just above the leur lock (lot (10)dr19j15023). Tubing discarded and platelets spiked with new tubing (lot#(10)dr19j15023). Platelets infused and completed without incident. Second bag of platelets spiked, tubing noted to be leaking again at the distal end of the tubing just above the leur lock (lot (10)dr19j15023). Tubing discarded and platelets spiked with new tubing (lot (10)dr19j15023) and second bag of platelets completed without difficulty. Manufacturer response for set, blood transfusion, clearlink (per site reporter). Our materials management team is in contact with the baxter representative and will hand-deliver this tubing to this representative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9670680 |
| MDR Report Key | 9670680 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-24 |
| Report Date | 2020-01-29 |
| Date Reported to FDA | 2020-01-29 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Added to Maude | 2020-02-05 |
| 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 | CLEARLINK |
| Generic Name | SET, BLOOD TRANSFUSION |
| Product Code | BRZ |
| Date Received | 2020-02-05 |
| Returned To Mfg | 2020-01-30 |
| Model Number | 2C8750 |
| Catalog Number | 2C8750 |
| Lot Number | (10)DR19J15023 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER INTERNATIONAL INC. |
| Manufacturer Address | 32650 N. WILLSON BLVD WGL-3N ROUND LAKE IL 60073 US 60073 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-05 |