MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SET D-100 manufactured by Smiths Medical Asd, Inc..
[184998313]
Information was received that upon priming the tubing on a smiths medical level 1 normothermic iv fluid admin set, blood placed on rapid infuser. Blood tubing for transfuser crack, delaying blood administration and waiting unit of blood. Tubing expired. Label on box with expiration, box itself does not have expiration date printed. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02193 |
| MDR Report Key | 9881834 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-02 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2015-08-20 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1 NORMOTHERMIC IV FLUID ADMIN SET |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA: KZL |
| Product Code | KZL |
| Date Received | 2020-03-26 |
| Model Number | D-100 |
| Catalog Number | D-100 |
| Lot Number | 3013262 |
| Device Expiration Date | 2019-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |