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

Catalog Number L259000309 - 100D2

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Fatigue (1849)

Event Date 02/26/2021

Event Type  Injury  

Manufacturer Narrative

According to the investigation performed, the affected sample and the samples from the leventons archive did not show the reported event.The affected unit was received and a residual volume of 26ml was recovered from the balloon.The unit was sent to a standardized flow rate test and no defects were observed.Samples from the same lot number retained in leventons archive were evaluated and underwent a functional test and the event could not be reproduced.The risk assessment was not reviewed because the event was unconfirmed.Several factors could affect the infusion time: the temperature of the solution in the container over 22ºc the temperature of the capillary element over 32ºc (equivalent to the skin temperature).The container and the output connection are not at the same level (container is in a higher position).

Event Description

Distributor indicated that on friday (b)(6) of 2021 around 3 p.M., the device was placed on the patient for a 5-fluorouracil (5-fu) infusion by healthcare professionals at the clinic.On friday evening, around 8 p.M., a wet spot was observed on the sweatshirt.On saturday noon ((b)(6) 2021) the diffuser was empty.5-fu was infused in 24 hours instead of 48 hours.According to the clinic, the infusion may have finished on friday evening.On sunday and the following days, the patient felt fatigue and the night from wednesday to thursday the patient felt respiratory oppression for 1 hour with a subsequent improvement.On thursday noon ((b)(6) 2021) the patient had irregular pulse and was hospitalized at the clinic for arrhythmia for 4 days.

• 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: 11771686
• MDR Text Key: 251670915
• Report Number: 9611707-2021-00001
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 08436020762956
• UDI-Public: 8436020762956
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/30/2022
• Device Catalogue Number: L259000309 - 100D2
• Device Lot Number: 201362L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization