MAUDE Adverse Event Report: VYGON USA FILTER, INFUSION LINE

Model Number AMS-426-1

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

There were three occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2019-00007, 2245270-2019-00008.Although the device was not returned to vygon, the details of the complaint will be examined as part of the complaint investigation.This investigation is currently in process and the results will be forwarded to fda within 30 days of its conclusion via follow-up mdr.

Event Description

(b)(6) called to report an incident regarding significant leak (puddle on floor by patient) from extension set near connection with pump.Leak involved hazardous chemo drug.Due to extent of contamination, all components, fluids, etc.Were disposed of as hazardous waste.No leakage noted until after patient was switched to ns flush bag.Pump did not beep or alarm.Pembrolizumab infused for 24 minutes and ns infused for 10ml.

• Brand Name: FILTER, INFUSION LINE
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: freda lacroix ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 8414033
• MDR Text Key: 139114231
• Report Number: 2245270-2019-00006
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K896333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AMS-426-1
• Device Lot Number: 1807049D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 84