MalfunctionLHI
MIX2VIAL
Received Jul 21, 2023 · Event occurred Jul 14, 2023
Report 17370066 · MDR key 17370066
Device
Generic name
Set, I.v. Fluid Transfer
Manufacturer
Csl Behring LlcProduct problems
- Defective Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A NURSE ATTACHED THE VIAL ADAPTERS THAT COME WITH THE MEDICATION TO THE VIALS AND THEN CONNECTED THE VIALS PER THE MFG INSTRUCTIONS. THE ADAPTERS ARE SUPPOSED TO FACILITATE THE TRANSFER OF THE DILUENT TO THE DRUG FOR RECONSTITUTION ONCE THE VIALS ARE CONNECTED. THE DILUENT DID NOT TRANSFER TO THE MEDICATION VIAL. THE ADAPTER SYSTEM DID NOT WORK. DRUG: KCENTRA 800-1240 IU VIAL, MFG: CLS BEHRING LLC, NDC: 63833-0387-02, LOT ON POWDER VIAL: P100503324 EXP: 5/20/25, LOT ON DILUENT VIAL: P100491458 EXP: 10/12/27.