MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-27 for LEVEL 1 HOTLINE BLOOD AND FLUID WARMER HL-390 manufactured by Smiths Medical Asd, Inc..
[185193012]
Device evaluation: returned device was received no physical damage found. The gasket material was replaced by the customer. Screws were torqued. Water was seen on the gasket once it was removed for inspection. During the evaluation of the device the customer reported condition was confirmed. Problem source is unknown. 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.
Patient Sequence No: 1, Text Type: N, H10
[185193013]
Information was received that a smiths medical level 1 hotline blood and fluid warmer had a "leaking fluid from the tank". No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02234 |
| MDR Report Key | 9887237 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-09-30 |
| Date Added to Maude | 2020-03-27 |
| 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 HOTLINE BLOOD AND FLUID WARMER |
| Generic Name | WARMER, THERMAL, INFUSION FLUID, PRODUCT CODE: LGZ |
| Product Code | LGZ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2020-03-06 |
| Model Number | HL-390 |
| Catalog Number | 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 | 2020-03-27 |