MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-25 for LEVEL 1 HOTLINE LOW FLOW SYSTEMS HL-390 CON-HL-390 manufactured by Smiths Medical Asd, Inc.
[184997190]
Evaluation results: one level 1 hotline low flow system was returned for investigation in used condition. The investigator noted a damaged tank cover, front cover, and a rusty drain fitting. The customer reported product problem was confirmed during testing. The device leaked at the bottom left corner of the tank cover. This was caused by a crack in the tanks cover. The tank cover, rusty drain fitting, and scratched front cover were all replaced. Preventative maintenance was then performed. The device subsequently passed all functional tests. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event. The problem source of the reported product problem was unknown. A root cause was not established.
Patient Sequence No: 1, Text Type: N, H10
[184997191]
It was reported that the device was leaking. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02307 |
| MDR Report Key | 9880996 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2017-12-18 |
| Date Added to Maude | 2020-03-25 |
| 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 | 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 | LEVEL 1 HOTLINE LOW FLOW SYSTEMS |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2019-10-01 |
| Model Number | HL-390 |
| Catalog Number | CON-HL-390 |
| 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 NORTH MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |