MAUDE Adverse Event Report: MEDIMOP MEDICAL PROJECTS LTD. / WEST PHARMACEUTICAL SERVICES INC. MIX2VIAL; SET, I.V. FLUID TRANSFER

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 12/26/2018

Event Type  malfunction  

Event Description

When attempting to mix vial of kcentra according to package instructions, the mix2vial transfer set did not function properly.The diluent was not immediately transferred upon assembly.Pharmacy staff withdrew the diluent volume via needle and syringe and manually added diluent to vial.Device malfunction lead to delay in therapy.Dates of use: (b)(6) 2018; diagnosis or reason for use: life threatening bleeding anticoagulation.

• Brand Name: MIX2VIAL
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): MEDIMOP MEDICAL PROJECTS LTD. / WEST PHARMACEUTICAL SERVICES INC.
• MDR Report Key: 8202847
• MDR Text Key: 131897468
• Report Number: MW5082655
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 57