MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERI

Model Number 4540018-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Nausea (1970); Hot Flashes/Flushes (2153)

Event Type  malfunction  

Event Description

As reported by the user facility: event 1 we have had some more issues with the easy pumps.Two more have finished early, like 24 hours.The pumps that are emptying too soon are the same ones we have had problems with cracking/leaking during filling them.Ii lt 270-54-s volume 270 ml, flow 5 ml/hr the medication in all cases is fluorouracil (chemotherapy) the patients got extremely nauseous, hot and flushed.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Two samples and one photo were received for further evaluation.The received samples and photo were taken to a visual inspection.Damages that would lead to a malfunction were not detected at one of the received samples.The sample with no defects was functionally tested and no damages were observed.Upon opening the top cap of the second sample, several cracks in the lli cone of the filling port were observed.The sample was leaked tested and failed.Incidents of this nature are due to failure in the production process.An approved project is in place to further address issues with leakage.A review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERI
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15769552
• MDR Text Key: 307223265
• Report Number: 9610825-2022-00459
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 22B07GE561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1