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

Model Number N/A

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/17/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.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.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in australia: "overinfusion".According to the customer: "infused too quickly.19.5h in a 24h pump.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).Device history record (dhr): reviewed the dhr for batch 21n06ge221, there is no abnormality and no such defect detected at in process and at final control inspection.Reviewed the final control flow rate (after eto) report, the average flow rate deviation from the nominal flow rate was between -3.22% and 3.46%.Sample evaluation: received one sample of easypump ii lt 270-27-s without original packaging.The batch number on the big bottom cap of the sample was 21n06ge221.Upon received, no solution was found in the sample and the sample was clamped.It was reported that the sample was used to be filled with flucloxacillin.Its filling port was closed with discofix cap, whereas its patient connector was not closed.Folded outer shell was observed.Flow rate test: the sample was decontaminated, unfolded, and sent for flow rate test (ltca-cmb9h8).The flow rate deviation from nominal flow rate for received sample was 0.20%.The flow rate of received sample was within the specification ±15% deviation from nominal flow rate.Conclusion: since the flow rate of received sample was within the specification, we considered this complaint as not confirmed.No deviation observed on the returned sample.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 II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B.BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16018961
• MDR Text Key: 308247161
• Report Number: 9610825-2022-00534
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K062700
• 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: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4540008
• Device Lot Number: 21N06GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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