MAUDE Adverse Event Report: ICU MEDICAL INC RIO DRUG RECONSTITUTION TRANSFER DEVICE; SET, I.V. FLUID TRANSFER

Lot Number 6040146

Device Problems Device Difficult to Setup or Prepare (1487); Product Quality Problem (1506); Improper Flow or Infusion (2954)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

Attached a 4.5 gram vial of piperacillin and tazobactam (apotex corp ndc 60505-6159-0 lot ah108026f2 exp 7/2023) to an ivpb bag of 0.9% sodium chloride injection, usp 100 ml (ndc 0990-7984-23 icu medical lot 6035874 exp jul 2024) utilizing a rio drug reconstitution transfer device (icu medical (b)(6) lot 6040146 exp 2023-06-01).Rn was able to activate system allowing fluid from the bag to enter the vial; after vial powder contents went into solution, she could only get approximately 1/2 of the fluid in the vial to return to the ivpb bag.She contacted the pharmacist and stated it was defective.She was provided another complete bag, vial, and transfer device.She again had the same issue and recontacted the pharmacist.The pharmacist pulled out the instruction illustrations for using the rio device, and along with the iv technician attempted to activate a third bag; even though they followed the provided instructions fully, they still could not get all the fluid from the vial to return to the bag.The iv technician prepared the ivpb traditionally using a syringe and adding to the ivpb bag (patient was an emergent transfer to another facility---product issues caused a delay in patient leaving).Reference reports mw5117237, mw5117238.

• Brand Name: RIO DRUG RECONSTITUTION TRANSFER DEVICE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): ICU MEDICAL INC
• MDR Report Key: 16876100
• MDR Text Key: 314717657
• Report Number: MW5117235
• 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: 05/01/2023

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: Health Professional
• Device Expiration Date: 06/01/2023
• Device Lot Number: 6040146
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2023
• Patient Sequence Number: 1
• Treatment: 0.9% SODIUM CHLORIDE 100 ML INJECTION USP.; PIPERACILLIAN AND TAZOBACTAM FOR INJECTION USP.
• Patient Outcome(s): Other