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 2020-02-12 for LEVEL 1 TRAUMA FAST FLOW DISPOSABLES DI-100 manufactured by Smiths Medical Asd; Inc..
[179132713]
Information was received indicating that a smiths medical level 1? Disposable liquid was observed to be dripping out above the drip chamber following adding pressure to the pressure chamber. The disposable was then reported to be changed out three times, but this situation was reported to occur each time. During this time, the patient was reported to be requiring resuscitation with other medication and therapy given. Unfortunately, the patient expired. The hospital reported "the death had nothing to do with the faulty systems. " the disposables were disposed of with no further information.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2020-00988 |
| MDR Report Key | 9702150 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-13 |
| Date Mfgr Received | 2020-01-14 |
| Device Manufacturer Date | 2011-07-01 |
| Date Added to Maude | 2020-02-12 |
| 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 N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL ASD; INC. |
| Manufacturer Street | 6000 NATHAN LANE N |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55442 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEVEL 1 TRAUMA FAST FLOW DISPOSABLES |
| Generic Name | DEVICE, WARMING. BLOOD AND PLASMA |
| Product Code | KZL |
| Date Received | 2020-02-12 |
| Model Number | DI-100 |
| Catalog Number | DI-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD; INC. |
| Manufacturer Address | 6000 NATHAN LANE N MINNEAPOLIS, MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-12 |