MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS DI-60HL manufactured by Smiths Medical Asd, Inc..
[183089767]
Device evaluation: returned device was received in good physical condition. During the evaluation of the device the sample was tested on a h-1200 fast flow fluid warmer and a leak was found between the tube and cap. The customer reported condition was confirmed. Problem source was traced to manufacturing. The device history record was reviewed and showed that no issues were identified that would have impacted this event.
Patient Sequence No: 1, Text Type: N, H10
[183089768]
Information was received that during a pre-use check a smiths medical level 1 disposable normothermic iv administration sets was found leaking from the tube. So they refrained from using it and replaced it with another new one. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-01977 |
| MDR Report Key | 9822079 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-11 |
| Date of Event | 2019-12-01 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-08-15 |
| Date Added to Maude | 2020-03-12 |
| 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 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SETS |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA, PRODUCT CODE: KZL |
| Product Code | KZL |
| Date Received | 2020-03-12 |
| Returned To Mfg | 2019-12-20 |
| Model Number | DI-60HL |
| Catalog Number | DI-60HL |
| Lot Number | 3840107 |
| 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 | 2020-03-12 |