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

Rodney 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.

Manufacturer Narrative

There were three occurrences within this complaint.Those occurrences were captured in the following mdrs: 2245270-2019-00006; 2245270-2019-00007; 2245270-2019-00008.Due to the harmful nature of the chemotherapy drug used in the product, the product was not able to be returned for investigation.Photographs were not returned as evidence for investigation.A review of the lot history record was performed, and no discrepancies were found.(b)(4) pieces were pulled to perform leak and occlusion testing and thirteen samples were pulled for bond pull testing.There were no failures identified in the aql in-process testing.Root cause: without evidence for investigation the failure cannot be confirmed, and a root cause cannot be identified.A two-year review of complaints showed no other complaints for the ams-426-1.Corrective and preventive action: corrective action: there is no evidence of failure to justify opening a corrective or preventive action at this time.Additionally, no other complaints have been received to indicate that this is a systemic issue.Vygon will continue to monitor for this issue and escalate as appropriate.

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
• MDR Report Key: 8286115
• MDR Text Key: 134454993
• Report Number: 2245270-2019-00008
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• PMA/PMN Number: K896333
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• 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
• Patient Sequence Number: 1
• Patient Weight: 84