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

Model Number 4540014

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Nausea (1970); Malaise (2359)

Event Date 11/14/2023

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in ukraine: "over infusion".According to the complainant, an oncological patient was undergoing chemotherapy treatment.The drug, fluorouracil - 4440 milligrams (mg) per 88.8 milliliters (ml) and sodium chloride 0.9% (388 ml), was introduced into the pump and administered to the patient.The patient returned home before the end of the infusion, and after completion, returned to the clinic for further treatment.Reportedly, the infusion completed twelve (12) hours earlier, and the patient complained about the rapid end of the infusion.The patient was noted as having nausea and general malaise.

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).A follow-up report will be provided after the examination results are 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.

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 22b18gea71 with article 4540014-20, there is no abnormality and no such defect detected at in process and at final control inspection.Sample/s evaluation: the flow rate report of affected batch 22b18gea71 was reviewed.For final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between (b)(4).Received 1 used and filled easypump ii lt 400-40-s-cis.As received condition, the clamp clip of received sample was clamped, and no wing cap was connected to the patient connector.Visual inspection had done throughout the received sample.No abnormality was observed.The sample was decontaminated and sent for flow rate test ((b)(4)).The flow rate deviation from nominal flow rate for received sample was (b)(4).The flow rate of received sample was within the specification (b)(4) deviation from nominal flow rate.Summary of root cause analysis: since the flow rate of received sample was within the specification, hence we considered this complaint as not confirmed.Cause : cause could not be determine.The flow rate of received sample was within the specification after sent for flow rate test, which is according to test method (b)(4) under lab condition.Justification: not confirmed.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 str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B BRAUN MELSUNGEN AG; carl-braun str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18445431
• MDR Text Key: 331915315
• Report Number: 9610825-2023-00639
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: UP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/05/2024

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 Model Number: 4540014
• Device Lot Number: 22B18GEA71
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: 56 YR
• Patient Sex: Female