MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for LEVEL 1 D-100 manufactured by Smiths Medical Md, Inc..
[119798848]
Initiated use of level 1 rapid infuser and the second chamber leaked and completely filled though was clamped off. Upon inspection appeared the seal between the spike and clear chamber failed and was leaking. The first chamber worked without issue. The second unit of blood on faulty chamber was subsequently un-spiked and then re-spiked with regular blood tubing. The patient was not injured or affected by the failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7863801 |
| MDR Report Key | 7863801 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-08-15 |
| Report Date | 2018-08-29 |
| Date Reported to FDA | 2018-08-29 |
| Date Reported to Mfgr | 2018-09-11 |
| Date Added to Maude | 2018-09-11 |
| 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 | LEVEL 1 |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2018-09-11 |
| Model Number | D-100 |
| Lot Number | 3147455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |