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

Model Number 4540008-07

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in portugal: "overinusion (18h instead of 24h)" according to the customer: "the institution's nurse reported that a patients' first pump of 24 hours infused in 18 hours, instead of the 24 hours as expected.In the meantime, the patient was discharged (this protocol has the duration of 4 days, and the patient starts the treatment at the hospital, and is discharged and finishes the treatment at home).He was contacted at the end of the treatment, and informed that the four pumps ran in 18 hours.The pumps were well measured and their weight was also measured, the measurement was manual and there was gravimetric control at the end, therefore we can guarantee that they had 240 ml.".

Manufacturer Narrative

This report has been identified as b.Braun internal report number (b)(4).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.Hc-pm complaint processing received no sample and no picture.To note: the combination of the article number 4540018-07 and the batch number 22c2bged registered in the cc-notification does not exist in the sap system, and therefore an examination is not possible if there were any abnormalities in the manufacturing process or in the check routine of the final control.The following investigations were conducted: visual inspection: no sample was received and thus a further evaluation and investigation of the complaint is not possible.Functional inspection: n.A.Physical inspection: n.A.Summary and assessment: as no sample and no picture was provided for investigation a malfunction could not be detected and therefore the complaint is considered as not confirmed.The complaint is only taken to knowledge and filed for statistical purposes.However, if the complaint sample will be provided, the complaint will be re-opened accordingly.The investigation sample(s) is/are not available.---------------------------------------------------------------------- bmi complaint management statement:- device history record (dhr):- the registered complaint batch 22c2bged41 does not exist in sap mya, thus, unable to review the dhr.Bmi received no sample and no picture for further investigation.Complaint to be forwarded to production.------------------------------------------------------------------- bmi complaint management supplementary statement:- the correct complaint batch and article had been updated.Device history record (dhr):- reviewed the dhr for batch 22c28ged41, 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 22c28ged41 was reviewed.For final control flow rate report, the average flow rate deviation from the nominal flow rate was between -1.01% and 3.62%.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 10 ml/hr to 11.8 ml/hr.Refer figure 1.Figure 1: ifu statement.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.Refer figure 2.Figure 2: ifu statement.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.Refer figure 3.Figure 3: ifu statement.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.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.

• 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: 17949885
• MDR Text Key: 326924856
• Report Number: 9610825-2023-00479
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4540008-07
• Device Lot Number: 22C28GED41
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• 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 Sex: Male