MAUDE Adverse Event Report: B BRAUN MEDICAL INDUSTRIES SDN. BHD. EASYPUMP ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

Model Number II LT 270-54-S

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/18/2020

Event Type  Injury  

Event Description

Patient scheduled on (b)(6) 2020 for folfox chemotherapy.The 46-hour take home fluorouracil dose was compounded in a b braun easypump elastomeric device (270-54-s).The correct drug, the correct drug and base solution volume and correct size/rate elastomeric device was used to prepare the 5fu dose for this patient as confirmed in the compounding camera images.The patient was admitted to the hospital on (b)(6) 2020 with rectal bleeding.Lab tests resulted plt of 9.At 4pm on (b)(6) 2020, it was also noted in the hospitalization record that the elastomeric device was empty.The elastomeric device containing chemotherapy set to infuse over 46 hours was attached on (b)(6) 2020 at 1148am.The device has an accuracy of infusion duration +/- 15% and should have ended between 448am and 348pm on (b)(6) 2020.The elastomeric ran to fast and emptied 11 hours early.Fda safety report id# (b)(4).

• Brand Name: EASYPUMP ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B BRAUN MEDICAL INDUSTRIES SDN. BHD.
• MDR Report Key: 10573887
• MDR Text Key: 208391686
• Report Number: MW5096817
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• 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: 09/21/2020

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 Model Number: II LT 270-54-S
• Device Lot Number: 20C10GE561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Weight: 62