MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-27 for RATE FLOW? US5300 manufactured by Leventon, S.a.u..
[122007428]
As reported by user facility: event 2. An "in house" test of the product using a 1 liter bag of fluid and the same gravity tubing that is being used in the community was performed. Customer did follow the directions for set up of the system including height requirements, etc. The flow regulator was set to infuse at 250 ml/hr, which should have infused over 4 hours, but the iv fluid ran through in just under 2 hours. No patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2532083-2018-00018 |
| MDR Report Key | 7914864 |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date Facility Aware | 2018-09-07 |
| Report Date | 2018-09-27 |
| Date Reported to FDA | 2018-09-27 |
| Date Reported to Mfgr | 2018-09-14 |
| Date Added to Maude | 2018-09-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RATE FLOW? |
| Generic Name | CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC |
| Product Code | LDR |
| Date Received | 2018-09-27 |
| Returned To Mfg | 2018-09-25 |
| Catalog Number | US5300 |
| Lot Number | 180946L |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEVENTON, S.A.U. |
| Manufacturer Address | NEWTON, 18-24 SANT ESTEVE SESROVIRES, BARCELONA 08635 SP 08635 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |