MAUDE Adverse Event Report: B.BRAUN MEDICAL INC. EASYPUMP GLASTOMERIC INFUSION PUMP; NONE

Device Problems Excess Flow or Over-Infusion (1311); Inadequate Instructions for Healthcare Professional (1319)

Patient Problem Overdose (1988)

Event Type  Other  

Event Description

My student xxxxx and i communicated with a pharmacist who reported that a patient received a fluorouracil infusion via an elastomeric mechanical pump called an easypump.This particular pump, from b.Braun, has two different rates available.One has a rate controller/filter in the built-in administration set that allows a flow of 2 ml per hour and the other is 250 ml/hour.Unfortunately the wrong pump was used.It was mentioned that carton labeling is nearly identical and the person choosing the device either did not know there was a difference or overlooked the rate because it is printed in a size that is hardly recognizable that someone (e.G, a pharmacy technician) would need to know that there are two different pump rates available.The patient was supposed to get 197 ml of fluorouracil ( i am trying to find out how many mg this represented) over 4 days but got the entire infusion in 1 hour instead.Very fortunately the patient just happened to have an appointment for radiation on the day this happened.A nurse there immediately recognized that there was no volume left in the pump.Vistonuridine was ordered to treat the overdose.The drug arrived a day later and the patient was brought in for treatment.The drug is given in 20 doses over 5 days.I am also trying to obtain follow up on patient condition.Likely i will use next week for a safety brief and will also call b.Braun today to discuss relabeling of cartons.Xxxxxxxx did find a similar case in the fda maude database so this is not the first time this mix-up has happened.Http://www.Accessdata.Fda.Gov/scripts/cdrh/cfdocs/cfmaude/detail.Cfm?mdrfoi__id=4353270.We also have had other fluorouracil overdoses that were tied to pump issues.(b)(4).

• Brand Name: EASYPUMP GLASTOMERIC INFUSION PUMP
• Type of Device: NONE
• Manufacturer (Section D): B.BRAUN MEDICAL INC.
• MDR Report Key: 4908679
• MDR Text Key: 6535543
• Report Number: MW5043988
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 05/27/2015

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2015
• Patient Sequence Number: 1