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

Model Number 4540006-07

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

As reported by the user facility information by bbm sales organization in germany: "chemo leakage".According to the customer: the infusion pump, filled with 5-fluorouracil and 0.9% nacl, was connected to the patient.It ran correctly at first then the pump leaked during the day, contaminating the patient's clothing and skin.According to the treating doctor, the pump is "cracked at the filter".The defective pump was returned to the pharmacy and is here.An on-site examination as well as a photo is not possible because the pump is heavily contaminated.

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.\ 1.General information: complaint: (b)(4).2.Information to the sample: 2.1 model: infusomat space.2.2 article number: 8713050.2.3 serial number/batch: (b)(6).2.4 software version: n030005.2.5 hours of operation: 2143.2.6 further information: n/a.3.Investigation results: 3.1 history inspection: the device history files were read and analyzed.Due to the lack of a precise error description, the history could not be analyzed extensively.The last infusions were investigated.No anomalies could be detected.3.2 visual inspection: a visual inspection was performed.The cover caps on the screw pillars, and the production seal on the lower housing were intact and undamaged.The device is in a clean state and no visible damage are to locate.3.3 functional inspection: a functional test was performed.The device passes the self-test.A space line was inserted, and the pump identified the line, and it could be selected from the menu.It was possible to put the pump in operation.3.4 pressure inspection: in checking the downstream-sensor the electronic pressure cut-off and the mechanical pressure limitation of the device were tested, according to the requirements of the technical safety check.The electronic pressure cut-off was checked: the device matches the required values and standards.All measured values are within our specification.3.5 flow rate inspection: a delivery accuracy measurement according to iec 60601-2-24 was arranged.Here a nominal flow rate of 100 ml/h was chosen.The assessed average deviation "a" of the second operating hour was measured and resulted in a value of +0,28%.((accuracy of set delivery rate should be: ± 5 % according to iec/en 60601-2-24) the device matches the required values and standards.All measured values are within our specification.3.6 disassembling: during the investigation no faults could be detected, to investigate the inside of the device, only the upper housing was removed.No damage or soiling could be found.4.Judgment: 4.1 the complaint could not be confirmed.Summing up all tests, the infusomat space operates within our specification.No product deviation.

• Brand Name: EASYPUMP 2
• Type of Device: ELASTOMERIC PUMPS
• 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: 18766408
• MDR Text Key: 336081661
• Report Number: 9610825-2024-00101
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/23/2024

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: 4540006-07
• Device Lot Number: 22N22GED3R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/22/2022
• 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