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..
[122010245]
As reported by the user facility: event 4- 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 harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2532083-2018-00015 |
| MDR Report Key | 7914862 |
| 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 |
| Model Number | US5300 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |