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

Model Number 4540008-02

Device Problem Improper Flow or Infusion (2954)

Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)

Event Date 02/13/2022

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.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: "pump-flow rate-fast." "connection at 5 p.M.(b)(6) 2022) - infusion stop at 3 a.M.(b)(6) 2022).Filling of the diffuser by the liberal nurse, means of filling: syringe.Visible air bubbles or kinks in the tubing: no.Ambient temperature.Catheter location: forearm and non-positional.Location of the diffuser: belt bag at the same level as the catheter, excluding clothing and blanket.Drug: acupan.The diffuser administered the 240ml over 10h instead of 24h, despite good filling of the idel (240ml).The incident occurred with all infusions since d1 friday (b)(6) 2022.Patient consequences: blood pressure disorders, palpitations, feeling of discomfort (no digestive disorders) at the end of the infusion and then rapid recovery in a few hours.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (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.We received three used and empty easy pump ii lt 270-27-s without packaging.Visual inspection had done throughout the sample.Folded outer shells were observed on all received samples.According to ifu, it was clearly mentioned under directions for filling, to unfold the outer layer properly prior to start the filling process.The samples were decontaminated and sent for flow rate test.The flow rate deviation from nominal flow rate for the received samples were 0.21%, 1.87%, and -1.85% from nominal flow rate.The flow rate of received samples were within the specification ±15% deviation from nominal flow rate.According to ifu, flow rate accuracy of the pump can vary at ± 15% deviation from nominal flow rate.However, 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 5 ml/hr to 5.9 ml/hr.Factor 2: 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.Factor 3: folded blow mold folded blow mold will also act as the external pressure to elastomeric membrane and increase the flow rate of the product.Factor 4: under filling of solution the under filling of solution might lead to sample empties faster than the nominal time.The under filling data is stated at the ifu.Folded outer shell was observed on the complaint sample and the complained fast flow rate is highly possible due to the folded blow mold which act as external pressure to the elastomeric membrane.Since the flow rate of received sample was within the specification, hence we considered this complaint as not confirmed.

• Brand Name: EASYPUMP® II
• 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, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 13608316
• MDR Text Key: 287188819
• Report Number: 9610825-2022-00069
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448485
• UDI-Public: (01)04046964448485(17)250301(10)20C12GE221
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081905
• 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: 11/21/2023

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 Model Number: 4540008-02
• Device Catalogue Number: 4540008
• Device Lot Number: 21A04GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 02/26/2022
• Supplement Dates Manufacturer Received: 02/17/2022
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1