MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-10-16 for RATE-FLOW US5300 L2590260-US5300 manufactured by Leventon S.a.u..
[124978550]
This event has been recorded in leventon s. A. U. As a customer complaint (reference (b)(4)). The defective unit was not returned to the manufacturer, thus the device was not evaluated. Six (6) units from the same manufacturing lot were retrieved from retained samples and successfully passed flow rate stability test and flow rate accuracy test. In addition, the batch record of the affected lot number was reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the controls done before the product release. Therefore, the defect reported by the customer could not be reproduced. Anyway, nothing justifies the occurrence of such an incidence. The position of 250 ml/h is the maximum value of the scale of the flow regulator. Then, if the directions for setting up the product according to the ifu are followed, it is not possible to get the double of flowrate in this position.
Patient Sequence No: 1, Text Type: N, H10
[124978551]
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 | 9611707-2018-00042 |
| MDR Report Key | 7969268 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-10-16 |
| Date of Report | 2018-09-27 |
| Date Mfgr Received | 2018-09-17 |
| Device Manufacturer Date | 2016-09-15 |
| Date Added to Maude | 2018-10-16 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DAVID SALVATIERRA |
| Manufacturer Street | NEWTON, 18-24 |
| Manufacturer City | SANT ESTEVE SESROVIRES, BARCELONA 08635 |
| Manufacturer Country | SP |
| Manufacturer Postal | 08635 |
| Manufacturer G1 | LEVENTON S.A.U. |
| Manufacturer Street | NEWTON, 18-24 |
| Manufacturer City | SANT ESTEVE SESROVIRES, BARCELONA 08635 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 08635 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RATE-FLOW |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | LDR |
| Date Received | 2018-10-16 |
| Model Number | US5300 |
| Catalog Number | L2590260-US5300 |
| Lot Number | 161332L |
| Device Expiration Date | 2019-09-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-10-16 |