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

Model Number	N/A
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
As reported by the user facility (translation of user facility information by bbm sales organization in france: "overinfusion." according to the customer: "they have a protocol of ketamine of 48mg in 48ml to be passed in 24h in subcutaneous way peri-umbilical.The diffuser empties in 16-17 hours.The nurse scrupulously respects all the filling recommendations attached and the patient is also vigilant.The problem has persisted for a week despite various attempts, even with a complete filling.The ketamine is therefore given for a much shorter time than prescribed.The patient does not feel any efficacy from her treatment but no side effects either.".
Additional 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 21n09ge231, there is no abnormality and no such defect detected at in process and at final control inspection.Root cause analysis: sample/s evaluation: final control flow rate report of affected batch 21n09ge231 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -1.16% and 6.01%.As no complaint sample was received, further investigation is not possible.There are some possibilities that can cause the sample empties faster than nominal time in actual application, such as one or combination factors of more than one as below: factor 1 temperature the temperature of the surrounding will affect the flow rate of the sample.For every increase of 1°c, the flow rate of the sample will increase approximately by 3%.For example, if the flow restrictor of the product reaches the temperature of 37°c, the flow rate of the sample will increase by approximately 18% which means the flow rate will increase from 2 ml/hr to 2.36 ml/hr.Factor 2 folded outer shell (outer layer) folded outer shell (outer layer) will also act as the external pressure to elastomeric membrane and increase the flow rate of the product.Factor 3 external pressure external pressure such as squeezing or laying on the pump will increase the flow rate which cause the pump to empty earlier than the nominal time.Simulation of external pressure had been conducted.The flow rate of the product can increase when external force is applied to the pump.However, this external force is against the intended use of the product according to ifu.Summary of root cause analysis: as no complaint sample was received, further investigation is not possible.Therefore, this complaint is considered as 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 II
• Common Device Name: 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: 16358322
• Report Number: 9610825-2023-00030
• Device Sequence Number: 6318910
• Product Code: MEB
• UDI-Device Identifier: 04046964448515
• UDI-Public: (01)04046964448515(17)261201(10)21N09GE231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 4540010
• Device Lot Number: 21N09GE231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown