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

Catalog Number 4540018-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 10/16/2023

Event Type  malfunction  

Event Description

As reported by the user facility: event 2: brief inquiry description: fast infusion causing nausea and vomiting of patient.Detailed inquiry description: per rn's report - this morning when patient woke up at 0430 her 5fu pump was already completely empty.It may have finished even earlier, but since she was asleep, she's not sure.She also experienced worse nausea this cycle than any of her previous cycles and had one incidence of emesis (which she took oral antiemetics for).It sounds like her pump has been finishing unusually early with previous infusions, but this time it was over 10 hours early, and she experienced worse side effects than previous cycles.Injury- nausea and vomitting.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: event 2: brief inquiry description: fast infusion causing nausea and vomiting of patient.Detailed inquiry description: per rn's report - patient arrived to the appointment today a bit before noon (his appointment was scheduled for 5:00pm) reporting that his bag had run dry around 0800 this morning.Per the mar, he was hooked up at 1705 on friday, so this dose finished about 9 hours early.He said that he was more nauseas yesterday than he had been with previous cycles, but otherwise denied new/worsening symptoms.Injury- nausea and vomitting.

Manufacturer Narrative

Event 2: this report has been identified as b.Braun medical internal report number 400624762.No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.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, ELASTOMERI
• 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 ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18077676
• MDR Text Key: 327442812
• Report Number: 9610825-2023-00510
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

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 Catalogue Number: 4540018-02
• Device Lot Number: 23F19GE561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 10/16/2023
• Supplement Dates FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male