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

Model Number	L2590263-V5922
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2023
Type of Reportable Event	Malfunction
Additional 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) and an additional point at 200ml/h as reported by the customer.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 warnings: 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.
Event or Problem Description
On may 12th 2023, medwatch voluntary report mw5117261 was received from us importer.Medwatch report mw5117261 states: received call from patient stating that her tigecycline infusion is going over 15 minutes and not the 30 minutes it should be.Patient confirmed that she had previously had no issue setting the rate flow to 200ml/hr for her 100ml infusion.Patient attempted to set the set to 150ml/hr but infusion is still infusing over 15 minutes.Patient reports that the lot for the v5922 tubing is 221201l.

• Brand Name: RATE FLOW
• Common Device Name: 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: 17078233
• Report Number: 9611707-2023-00001
• Device Sequence Number: 15017722
• Product Code: FPA
• UDI-Device Identifier: 08436020767302
• UDI-Public: 08436020767302
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K952810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/16/2025
• Device Model Number: L2590263-V5922
• Device Lot Number: 221201L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown