MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP 2; ELASTOMERIC INFUSION PUMP

Catalog Number 4540018-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Arrhythmia (1721); Diarrhea (1811); Nausea (1970)

Event Date 12/13/2023

Event Type  malfunction  

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.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility information by bbm sales organization in switzerland: "easypump overinfusion" according to the complainant, on (b)(6) 2023, the patient was setup on an easypump to have 3600 milligrams (mg) fluorouracil in 240 milliliters (ml) nacl 0.9% administered over 48 hours.The easypump was programmed to infuse the medication at 5 ml per hour (ml/h).However, when the patient woke up the morning of december 13th, the bag was empty.The therapy had completed after approximately 36 hours.Reportedly, the patient experienced diarrhea, nausea, and a heart rhythm disorder.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Root cause analysis: device history record (dhr):- reviewed the dhr for batch 23g13ged91, there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: final control flow rate report of affected batch 23g13ged91 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -9.20% and -3.27%.As no complaint sample was received, further investigation is not possible.Cause : cause could not be determine.As no complaint sample was received, further investigation is not possible.Corrections/containment plans with effective date: not applicable corrective actions with effective date: not applicable justification: not confirmed.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: EASYPUMP 2
• Type of Device: ELASTOMERIC INFUSION PUMP
• 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: 18596252
• MDR Text Key: 335080760
• Report Number: 9610825-2024-00045
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 4540018-07
• Device Lot Number: 23G13GED91
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/13/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Sex: Female