MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL, LTD. MIX2VIAL; SET, I.V. FLUID TRANSFER

Lot Number P100505724

Patient Problem Insufficient Information (4580)

Event Date 10/22/2023

Event Type  malfunction  

Event Description

We have a recurring issue with csl behring idelvion ix.We've reported this issue through our special pharmacy, and our hemophilia treatment center has also had the same issue and reported it to the manufacturer, but the manufacturer has not taken any action to correct it.Idelvion requires using a mix2vial device to combine the medicine with a saline diluent.However, approximately once every 3-4 times, the mix2vial fails to work, leaving no way to combine the medicine and saline.In addition to being frustrating, it is a safety issue, since it requires patients either to delay taking their medicine until the manufacturer can send a replacement or use the medicine off label by mixing saline directly into the medicine vial.

• Brand Name: MIX2VIAL
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): WEST PHARMA. SERVICES IL, LTD.
• MDR Report Key: 18093524
• MDR Text Key: 327716400
• Report Number: MW5147900
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/22/2023

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 Lot Number: P100505724
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 20 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White