MAUDE Adverse Event Report: LEVENTON S.A.U. RATE FLOW; REGULATOR IV SET

Model Number L2590263-V5922

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  malfunction  

Event Description

On june 5th 2023, medwatch voluntary report mw5117708 was received from us importer.Medwatch report mw5117708 states: received call from patient stating that her metronidazole infusion is infusing over 30 minutes instead of the 60 minutes it should be.Patient reports that the lot for the v5922 tubing is 221201l.

Manufacturer Narrative

Investigation: the review of our internal nonconformance and complaint systems did not identify any quality issues or trends in the batch record of the possible affected product.As the unit related to this complaint was not kept for inspection, an exhaustive evaluation of the informed defect was not possible and only the units from the archives of samples were evaluated.Retained units of the affected lot from the leventon's archive of samples were sent to a flow accuracy test.All units were assessed at three flow rates (low, mid and high).All results were within specifications.Conclusion: the event could not be confirmed as the affected samples could not be assessed.It is very important to have the faulty unit of every complaint informed to do accurate evaluations of the possible causes of the informed defects.For a correct operation of the device instructions of use must be followed, highlighting the following warnigs: the level of the solution to be administered must be at 80cm above the patient midaxillary line.The flow rate must be always be verified by counting drops, the scale on the device is only a reference for this setting.Do not set the regulator near the open position; flow rates up to 2500ml/h could be reached.

• Brand Name: RATE FLOW
• Type of Device: REGULATOR IV SET
• Manufacturer (Section D): LEVENTON S.A.U.; ronda can margarit 38; pol. ind. can margarit; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer (Section G): LEVENTON S.A.U.; ronda can margarit 38; pol. ind. can margarit; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer Contact: david salvatierra ; ronda can margarit 38; pol. ind. can margarit; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 17180787
• MDR Text Key: 318227088
• Report Number: 9611707-2023-00002
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 08436020767302
• UDI-Public: 08436020767302
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L2590263-V5922
• Device Lot Number: 221201L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1