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 10/13/2018

Event Type  Injury  

Event Description

Patient experienced tachysystole after oxytocin was begun at 1 milliunits/min.The nurse mixed the drug using vial2bag device with 2 vial connectors and 2 vials of drug.The nurse immediately stopped the drug and administered a bolus of lactated ringers and oxygen.The oxytocin was then restarted at the same initial rate, but the rate now had to be increased due to no response with lower doses.The dose was increased up to 5 milliunits/min.This was then reported through the hospital event reporting system and it was learned from nursing that other patients 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 occurred.It began to raise suspicion that pooling of the drug was taking place and patients were potentially receiving a bolus of drug after hook up.Background - august 9th, medical centers supplier of oxytocin alerted pharmacy that they were temporarily ceasing production of the 20 unit/1 l oxytocin formulation, this was the product carried at the medical center.However, they were continuing to produce the 30 units/500ml concentration, but this was on allocation and our allocation was zero.At that time, we had an estimated stock of 1 week.August 10th, ob was given several options: first, pharmacy could compound and store under refrigeration on the unit (needed to extend stability).Second, compound on unit using vial2bag (2 vial set up).Third, compound on unit using vial2bag with 1 vial and 500ml bag (same concentration but half the volume; which would require system ordering changes).August 14: ob chose for pharmacy to compound and store under refrigeration until we could potentially change to the different concentration of 30 unit/500ml.Nurses expressed dissatisfaction with how "cold" the bags were and due to space constraints, bags were only available at one nursing station.September 28; ob leadership decided to approach pharmacy about possibly trying the vial2bag system.October 4th: after assessment of available products and education to the maternity nursing staff, the decision was made to use this vial2bag device.Hospital went live with vial2bag for mixing oxytocin on the unit which was meant to allow for more convenient access to the drug, as well as having it at room temp (as opposed to a refrigerated bag from the pharmacy compounded bag).October 15th: ob leadership contacted pharmacy with concerns raised by nurses regarding variability in efficacy.The manufacturer was notified; email was sent to rep detailing the issue.System hospitals were also contacted about the issue and change.For the short term, nursing was instructed to use needles access device in mix oxytocin when needed.Use of vial2bag was immediately abandoned.October 16th, rep called back for more info, escalated report to clinical team and initiated produce incident report.October 17th: steps were taken to begin the transition to the new concentration; changes to alaris, alerted providers, educated staff.Pharmacy resumed compounding for the time being.October 18th: estimated receipt of premixed bags of 30unit/500ml bags.An internal investigation is currently underway to determine how many patients were affected with similar reactions.As of right now, we have 5 patients that experienced tachysystole while on oxytocin.There have also been 3 cases reported for hemorrhage that could've been due to a diluted administration.

• 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: 8198089
• MDR Text Key: 131515336
• Report Number: 3000223297-2018-00005
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 07290108240061
• UDI-Public: (01)07290108240061(17)210601(10)9994(90)36098125(91)6070111
• 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 Expiration Date: 06/01/2021
• Device Model Number: 6070111
• Device Lot Number: 9994
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• 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