MAUDE Adverse Event Report: WEST PHARMA. SERVICES IL WEST PHARMA. SERVICES IL VIAL2BAG DC 13MM

Model Number 6070111

Device Problems Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Pt x experienced tachysystole about 5 mins after oxytocin was begun at 2 milliunits/min per usual oxytocin induction orders.The nurse mixed the drug using vial2bag device with 2 vial connectors (13 mm} and 2 x 1 ml vials of drug.The nurse immediately discontinued the drug and administered a bolus of lactated ringers; then oxytocin was started again with the same immediate effect.The drug was discontinued.After this was reported it was learned that other nurses experienced similar effects from the drug.In other words, they were experiencing immediate, intense, unexpected effects of the drug as soon as it was begun, and before any titration occured.It began to raise suspicion that pooling of the drug was taking place and pts were potentially receiving a bolus of drug after hook up.Background xxx recently switch to nurse-admixed oxytocin to allow for more convenient access to the drug, as well as having it at room temperature (as opposed to a refrigerated bag from the pharmacy compounded bag}.After assessment of available products and education to the maternity nursing staff, the decision was made to use the vial2bag product by (b)(4).Assessment: when pharmacy learned of the reported event, the decision was made to immediately discontinue point of care admixture and the resume pharmacy compounded oxytocin.In addition, a test was set up using food coloring and/or colored drugs to visualize what was happening.Exact set ups were created to mimic norepinephrine, dexmedetomidine, and oxytocin the three drugs being admixed in this manner in the hospital.The findings were that pooling was occurring with the oxytocin set up but not the others.You can see that a small amount of concentrated drug is stuck in the tubing and will not travel up to the bag.This is the site where the iv spike i tubing is inserted.Recommendation: the company was notified and is beginning internal investigation.They made visit on (b)(6) 2018 to (b)(6).Immediate discontinuation of this process for oxytocin occurred on (b)(6) 2018.Investigation of other pts is underway.Reviewing potential cases of postpartum hemorrhage possibly related to subtherapeutic oxytocin.Shared with (b)(6) hospital pharmacy leaders.Reporting to fda and (b)(4).Reporter's recommendations: the company was notified and is beginning internal investigation.They made a visit on(b)(6) 2018 to (b)(6).Immediate discontinuation of this process for oxytocin occurred on (b)(6) 2018.Investigation of other pts is underway.Reviewing potential cases of postpartum hemorrhage possibly related to subtherapeutic oxytocin.Shared with (b)(6) hospital pharmacy leaders.Reporting to fda and (b)(6).(b)(6), access number: (b)(4).

• Brand Name: WEST PHARMA. SERVICES IL VIAL2BAG DC 13MM
• Type of Device: VIAL2BAG DC 13MM
• Manufacturer (Section D): WEST PHARMA. SERVICES IL; 4 hasheizaf street; ra'anana hamerkaz, 43664 11; IS 4366411
• MDR Report Key: 8198201
• MDR Text Key: 131477969
• Report Number: 3000223297-2018-00012
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: K170095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6070111
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: RES81877
• Patient Sequence Number: 1
• Treatment: OXYTOCIN
• Patient Outcome(s): Required Intervention