MAUDE Adverse Event Report: LEVENTON DOSI-FUSOR; PUMP, INFUSION, ELASTOMERIC

Lot Number 1707101L

Device Problem Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/09/2017

Event Type  malfunction  

Event Description

Using leventon portable dosi-fusor lv 5.2 2.1 ml for outpatient chemo pts.Have had 4 incidents of the chemo leaking at the capillary sensor (taped to the skin of the pt), has leaked and caused the chemo to crystalize outside of the pt's body.Contacted the distributor, (b)(4), pulled and returned all catalog of product code #250d5 with lot #170101l (22 each) for qa by mfr.Portable chemo pump used in hematology oncology practice.

• Brand Name: DOSI-FUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): LEVENTON
• MDR Report Key: 6894017
• MDR Text Key: 87516543
• Report Number: MW5072429
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2017

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: No Information
• Device Expiration Date: 01/16/2019
• Device Lot Number: 1707101L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other