MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER; ELASTOMERIC PUMP FOR DRUG INFUSION

Device Problem Failure to Infuse (2340)

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

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

With the information available to date, no reference nor lot number is available.Therefore, quality records could not be reviewed.Last lot number sold in the us was 181467l, expiry date 12th july 2020.The expiry date is before the event date reported, (b)(6) 2021, suggesting product may have been used after the expiry date.According to the manufacturer's risk managment file (rmf) the type of event malfunction with no infusion has an acceptable risk due to its severity and probability of the event.The root cause of the event could not be determined.This report is being submitted to provide manufacturer investigation to fda report mw5100038 identified through maude database search.

Event Description

The device was placed on the patient on wednesday (b)(6) 2021 and sent home.When he came back for disconnection on the same day, the pump had not infused any of the medication.The patient refused to be re-treated with a second pump due to work related issues with the awareness of the clinical team.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC PUMP FOR DRUG INFUSION
• Manufacturer (Section D): LEVENTON S.A.U.; newton 18-24; polígono industrial sesrovires; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer (Section G): LEVENTON S.A.U.; newton 18-24; polígono industrial sesrovires; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer Contact: david salvatierra ; newton 18-24; polígono industrial sesrovires; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 11843525
• MDR Text Key: 262443373
• Report Number: 9611707-2021-00002
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2021

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/08/2021
• Initial Date FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1