MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-27 for LEVEL 1 HOTLINE LOW FLOW SYSTEM L-70NI manufactured by Smiths Medical Asd, Inc.
[185237284]
Evaluation results: one level 1 hotline disposable was received for investigation in used condition. The sample was visually inspected at a distance of 12 to 24 inches and under normal conditions of illumination. The investigator noted that there was a deformation in the connector. 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. The investigator suspected that the connector reflux became damaged after the product left the manufacturing facility. A definitive root cause was not established however.
Patient Sequence No: 1, Text Type: N, H10
[185237285]
It was reported that the twin-tube connectors were bent and sticking together. The operator was unable to insert the tube into the socket of the level 1 hotline low flow system (hl-90). The product problem was observed upon opening. No patient injury or complications were reported in relation to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-02279 |
| MDR Report Key | 9888910 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-27 |
| 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 | 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 | 2020-03-27 |
| Returned To Mfg | 2019-12-26 |
| Model Number | L-70NI |
| Catalog Number | L-70NI |
| Lot Number | 3806399 |
| Operator | HEALTH PROFESSIONAL |
| 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 |