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..
[184999242]
One smiths medical fluid warmer was returned for analysis with damaged enclosure, tank cover, front cover, 390 block, pole clamp and line cord. During analysis, tank was filled with water, attached temperature check, plugged in line cord, and turned on power switch, and the reported issue was confirmed. A damaged 390 block was noted on the main section and was the cause of the reported problem. Service replaced the main, left, and right pieces of the block to correct the reported problem. Based on the evidence, the complaint was confirmed, and the problem source of the reported event was noted to be a damaged 390 block (main section).
Patient Sequence No: 1, Text Type: N, H10
[184999243]
Information was received indicating that a smiths medical fluid warmer was noted to be leaking. It was not specified whether this occurred during infusion or interrupted therapy. No adverse effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02371 |
| MDR Report Key | 9878496 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2012-07-16 |
| 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 | 2019-09-11 |
| 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 | 2020-03-25 |