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

Model Number L25915-100D2-FDA

Device Problem Fluid/Blood Leak (1250)

Patient Problems Skin Irritation (2076); Caustic/Chemical Burns (2549)

Event Date 10/02/2015

Event Type  malfunction  

Manufacturer Narrative

This event has been treated in leventon (b)(4) as an incidence (internal code for customer complaint: (b)(4)).We consider that the defect detected by the client is an occasional defect according aql's (acceptable quality level) that could be due to any leakage at one point of the capillary element's welding area that could cause the precipitation of the drug stopping this leakage.It must be taken into account that all the capillaries are tested for leakages 100% before use at 2 bars.So, we consider that the root cause of the defect could be: the unit has not been tested for leakages by human error during the manufacturing process and this defect was not detected in the control made by sampling before the release of this product.The unit has been accidentally subjected to a force resulting in a break of the welding.

Event Description

A dosi-fuser 100ml 2 day infuser was used for a 2 day infusion of fluorouracil.When patient returned to clinic to disconnect dosi-fuser, notified nurse of white powder around restrictor element.Nurse in turn notified pharmacist, who witnessed white powder.Upon inspection, pharmacist and nurse determined the restrictor element may be either cracked or not sealed properly.Nurse wiped the powder from patient's chest and minor skin irritation was noted.During a two week return visit, patient stated the skin became red and irritated, but was at the moment healing and brown in color.Appears to possibly be a chemical burn from the fluorouracil.No further treatment of the area was needed and the patient continued chemotherapy.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona, spain 08635 ; SP 08635
• Manufacturer Contact: david salvatierra ; newton 18-24; sant esteve sesrovires, barcelona, spain 08635 ; SP 08635 ; 93 8176300
• MDR Report Key: 5687594
• MDR Text Key: 46185771
• Report Number: 9611707-2016-00001
• 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: Pharmacist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/06/2016

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: Other
• Device Expiration Date: 03/31/2017
• Device Model Number: L25915-100D2-FDA
• Device Catalogue Number: L25915-100D2-FDA
• Device Lot Number: 150431L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2015
• Initial Date FDA Received: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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