MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for LEVEL 1 NORMOTHERMIC IV FLUID ADMINISTRATION SET D-100 manufactured by Smiths Healthcare.
[96886949]
Patient Sequence No: 1, Text Type: N, H10
[96886950]
During massive transfusion protocol, rn initiated infusion of platelets via rapid infuser and immediately noticed dripping outside of chamber where platelet bag was spiked. Infusion was stopped and all connections and bag were checked for holes and none were found. Infusion was restarted, again dripping was noted immediately. Infusion was stopped, tubing was changed and infusion restarted. No further dripping was noted. Manufacturer response: for iv fluid administration set, level 1 normothermic iv fluid administration set (per site reporter). Equipment complaint reported. Biohazard return kit requested. Tubing flushed with bleach solution. Product will be returned to smith medical when biohazard return kit arrives.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7178171 |
| MDR Report Key | 7178171 |
| Date Received | 2018-01-10 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-12-14 |
| Report Date | 2017-12-18 |
| Date Reported to FDA | 2017-12-18 |
| Date Reported to Mfgr | 2017-12-18 |
| Date Added to Maude | 2018-01-10 |
| 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 |
| 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 | LEVEL 1 NORMOTHERMIC IV FLUID ADMINISTRATION SET |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2018-01-10 |
| Catalog Number | D-100 |
| Lot Number | 3179924 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS HEALTHCARE |
| Manufacturer Address | 1265 GREY FOX ROAD ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-10 |