MAUDE Adverse Event Report: CSL BEHRING LLC. MIX2VIAL WITH KCENTRA; SET, I.V. FLUID TRANSFER

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/26/2022

Event Type  malfunction  

Event Description

Three out of four mix2vial transfer sets failed when nurse attempted to reconstitute vials necessitating work around to get vials reconstituted and then contents withdrawn.Rn ended up using the closest available syringe - one filled with nss that she squirted the nss out and used to reconstitute product of one vial.One of five mix2vial transfer sets failed to transfer diluent within the last 60 days when mixed in the pharmacy for another order but was not reported because it was thought to be a one-off event.Fda safety report id # (b)(4).

• Brand Name: MIX2VIAL WITH KCENTRA
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): CSL BEHRING LLC.
• MDR Report Key: 13966147
• MDR Text Key: 288387952
• Report Number: MW5108642
• Device Sequence Number: 4
• Product Code: LHI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/28/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Race: White