MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-09 for SMITHS MEDICAL LEVEL 1 HOTLINE TRAUMA FAST FLOW SYSTEMS 8002950 manufactured by Smiths Medical Asd, Inc..
[182562317]
One fluid warmer was returned for evaluation. Visual inspection of the device found it to be in fair condition, with air detector door removed by customer. Device underwent functional testing by attaching a f-30 gas/vent filter to air detector and powered it on. The air detector clamp test was completed and the plunger retainer was noted to be stuck halfway and then would clamp all the way down. This confirms the reported customer allegation, as a result of faulty solenoid. The problem source has been determined to be unknown. While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.
Patient Sequence No: 1, Text Type: N, H10
[182562318]
Information was received that the clamp on a smiths medical level 1 trauma fast flow system will not work its way down when the cassette is removed. No adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01900 |
| MDR Report Key | 9805888 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date Mfgr Received | 2020-02-11 |
| Device Manufacturer Date | 2007-04-09 |
| Date Added to Maude | 2020-03-09 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH SUITE 100 |
| Manufacturer City | OAKDALE, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMITHS MEDICAL LEVEL 1 HOTLINE TRAUMA FAST FLOW SYSTEMS |
| Generic Name | WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION |
| Product Code | BSB |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2019-10-02 |
| Model Number | 8002950 |
| Catalog Number | 8002950 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |