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

Model Number 4540016-07

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

According to the complainant, the patient was prescribed fluorouracil (5fu), 4250 milligrams (mg) to be infused over 46 hours.The calculation was made and completed with saline solution for the volume infusion pattern.The infusion pump was installed at 12:30 pm with the device operating within its normal limits, no observations being made that would compromise flow, and no leaks identified.However, at 3:40 pm, the patient returned to the hospital, where it was observed that the elastomeric pump had a leak at the filter.All medication was discarded as a result of this event.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.

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.As there is no sample provided, further investigation is not possible.The investigation is done based on customer description and diagram provided.Referring to the diagram provided, leakage was seen from the filter inlet port (refer figure 1).Review history record, such defect was caused by crack line at filter inlet port.Figure 1: diagram from customer.Filter is a supplied component.The affected filter batch of this production lot is 229254.With no sample provided, we are not able to identify the exact root cause.However, an approved project has been raised to address crack at filter inlet port issue.Summary of root cause analysis: the defect mentioned can be clearly seen from the picture provided.Hence, this complaint is considered as confirmed.

• 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: 19135684
• MDR Text Key: 341013245
• Report Number: 9610825-2024-00276
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/18/2024

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: 4540016-07
• Device Lot Number: 22F03GED8R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/03/2022
• 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 Age: 71 YR
• Patient Sex: Male