MAUDE Adverse Event Report: VYGON USA IV EXT SET 7" 0.2 MICRON FILT; FILTER, INFUSION LINE

Model Number AMS-427

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

(b)(6) nurse (b)(6) spontaneously called in, stated that the she was having difficulties with the administering the infusion of adakveo through the 2.0 micron filters dispensed.She stated that the infusion was supposed to take 30 mins, but took 1 hour and 45 minutes.She stated that she opened up the filter all the way, but it still was slowly infused.She is requesting that an alternative brand be shipped at next fill to decipher if it's the micron filter itself, or if the one that was used during administration was defective.Reported to (b)(6) by health professional.

• Brand Name: IV EXT SET 7" 0.2 MICRON FILT
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): VYGON USA
• MDR Report Key: 10747748
• MDR Text Key: 213672437
• Report Number: MW5097486
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): Y
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AMS-427
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1