MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number 4540018-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Muscle Weakness (1967); Pericarditis (4448)

Event Date 01/26/2022

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.

Event Description

As reported by the user facility: pump infused faster than expected, while patient was at home.Customer thinks temperature may have affected the infusion."the patient is a (b)(6) male.The medication was fluorouracil.The patient was actually being seen in our emergency department due to weakness/stemi and the chemo nurse was asked to come disconnect the iv pump and she reported it was completely done infusing.The pump had been started 1/26 around 2 pm and the nurse removed the pump while the patient was in the ed on 1/27 around 6:30-7 pm.So the pump maybe infused over around 30 hours and was supposed to go for 46 hours.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No sample was returned, no sample could be evaluated.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13571025
• MDR Text Key: 286079935
• Report Number: 9610825-2022-00029
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 21C12GE561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/21/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male