MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-24 for LEVEL 1 HOTLINE LOW FLOW SYSTEM HL-390 CON-HL-390 manufactured by Smiths Medical Asd, Inc.
[184813205]
Evaluation results: one level 1 trauma fast flow system was returned for investigation in used condition. Upon physical inspection the investigator noted the following: a damaged enclosure, a stripped interlock block, and a main block. The aforementioned components, along with the main block, were replaced as a result. The customer reported product problem (leaking) was confirmed. The product problem was attributed to normal wear and tear. This was identified as the root cause.
Patient Sequence No: 1, Text Type: N, H10
[184813206]
It was reported that the unit had crack on the bottom enclosure and was leaking as a result. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02252 |
| MDR Report Key | 9875514 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2017-02-27 |
| Date Added to Maude | 2020-03-24 |
| 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 SYSTEM |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2019-09-12 |
| 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 | 2020-03-24 |