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

Catalog Number 4540008-07

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Nausea (1970); Malaise (2359)

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 france: "overinfusion." according to the cusomer: "they had 3 diffusers which passed twice as fast as the time indicated, despite the good practices of the liberal nurse.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report # (b)(4).Event 2: we received one used, empty easypump ii lt 270-27-s-eu/sa without packaging and one easypump ii lt 270-27-s-eu/sa in original packaging.The following investigations were conducted: visual inspection: the received samples were taken to a visual inspection according test method for damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: weight of the samples were-received condition: sample 1: 71.6 g.Sample 2: 72.6 g.As-received condition the white clamp was closed.The patient connector was open, and the filling port was closed with the closing stoppers discofix.Furthermore, we detected solution at the filling port (lli-cone) and at the patient connector (lla-cone) at the used sample.Damages that would lead to a malfunction were not detected at the received samples.Functional inspection: afterwards the samples were taken to a functional test respectively a leak test was carried out.Therefore, the pumps were approximately filled up to the nominal volume of 270 ml with nacl 0.9 %.After starting the pumps, the pumps worked immediately (solution was running).Leakage was not detected at the received samples.Physical inspection: furthermore, the flow rate of the pumps was tested.Nominal: 10 ml/h.Actual: used sample: 17.2 ml in 1 h; 30.2 ml in 2 hrs; 189.2 in 18 hrs.Sample in original packaging: 18.2 ml in 1 h; 34.3 ml in 2 hrs; 193.7 in 18 hrs.The decisive value to evaluate the flow rate will be measured approx.At the half of the pump running time.The flow rate of the pumps is within the specification.Summary and assessment: a too fast flow of the pumps (as described by the customer) could not be determined.Based on the conducted investigations the tested samples are within the specification.Therefore, the complaint is considered as not confirmed.Device history record (dhr): reviewed the dhr for batch 22g26ged41, there is no such defect detected at in process and at final control inspection pertaining flow rate issue.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 ; 861 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17299114
• MDR Text Key: 319471218
• Report Number: 9610825-2023-00350
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/09/2023

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: 4540008-07
• Device Lot Number: 22G26GED41
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/11/2023
• Supplement Dates Manufacturer Received: 06/22/2023
• Supplement Dates FDA Received: 11/09/2023
• 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