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 HOTLINE 3 BLOOD AND FLUID WARMER CON-HL-390 manufactured by Smiths Medical Asd, Inc..
[185268265]
Returned device was received in decent physical condition. The enclosure, tank cover, front cover, and faded line cord were all damaged. During the evaluation of the device, the tank was filled with water, the temp check was attached and the in line cord was plugged in and the power switch was turned on. It was found that water was leaking from the lower right corner of the tank cover. The tank cover was found to be the cause of the complaint. This will be replaced. 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
[185268266]
Information was received indicating that a smiths medical fluid warmer had a leak. No adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02372 |
| MDR Report Key | 9889782 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2012-03-22 |
| 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 Phone | 3833310 |
| 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 | HOTLINE 3 BLOOD AND FLUID WARMER |
| Generic Name | WARMER, THERMAL, INFUSION FLUID |
| Product Code | LGZ |
| Date Received | 2020-03-27 |
| Returned To Mfg | 2019-09-11 |
| 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 | 2020-03-27 |