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 SYSTEM CON-HL-390 manufactured by Smiths Medical Asd, Inc..
[184999819]
One smiths medical fluid warmer was returned for analysis with wear and tear damage enclosure front cover, tank cover, line cord, and pole clamp and a missing block assembly. During analysis, the returned sample was started with a visual inspection and once the missing block assembly was replaced the tank was filled with water, attached temperature check, plugged in line cord, and turned on power switch but the reported problem was not duplicated but another issue was found with a missing block connector. Service replaced missing block assembly to correct the issue found. Based on the evidence, the complaint was not confirmed, and another issue was found with a missing block connector.
Patient Sequence No: 1, Text Type: N, H10
[184999820]
Information was received indicating that a smiths medical fluid warmer displayed replace old connectors. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02369 |
| MDR Report Key | 9878497 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2019-08-12 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2015-12-01 |
| 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 Phone | 3833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | 3350 GRANADA AVENUE NORTH |
| 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 | 2020-03-25 |
| Returned To Mfg | 2019-10-02 |
| 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 |