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

Model Number 4540018-02

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 05/29/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: pump leaked an unidentified amount of 5fu infusion on patient during 48hr at-home infusion.Leak was occurring at the base of cap where diluent/drug is admixed.No injury reported.

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

This report has been identified as b.Braun medical internal report number (b)(4).Hc-pm complaint processing received no sample and no picture.The following investigations were conducted: visual inspection: no sample was received and thus a further evaluation and investigation of the complaint is not possible.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.Bmi complaint management statement:- bmi received no sample and no picture for further investigation.Complaint to be forwarded to production.Root cause analysis: measure: refer to manufacturing sop of elastomeric infusion system: 1.Hc-my01-m-5-4-16-002-0.2.Hc-my01-m-5-4-16-012-0.3.Hc-my01-m-5-4-16-015-0.4.Hc-my01-m-5-4-16-044-0.Sample/s evaluation: neither sample nor picture is available, hence further investigation to identify the defect as customer description is not possible.Analysis: according to customer's descriptions, leaking occurring at the base of cap where diluent/drug is admixed.Further inquiry was posted to understand the description "leak was occurring at the base of cap where diluent/drug is admixed.' addition information (it was from the top.Leaking while being filled before patient use.') was updated in the sap.Reviewing the historical data and information provided, below are the potential root causes of leakage at the area described by the customer: 1.Valve leakage.2.Leakage due to crack at filling port.3.Leakage due to crack at bht.Valve leakage and crack at filling port are known issue and capa 172512 and capa 205388 have been initiated to address the issue.Awareness training was conducted (completion date: 2022-12-08 and 12-30) to the molding and assembly operators on the crack line at bht.Operators have to immediately inform supervisor if crack at bht is observed for immediate action.Further investigation will be conducted to identify the actual leakage point if the sample returns.Summary of root cause analysis: as neither complaint sample nor picture was received, further investigation is not possible to identify the complained defect.Hence, the complaint is classified as not confirmed.Cause : cause could not be determined neither sample nor picture is available, hence further investigation to identify the defect as customer description is not possible.

• 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: 17162183
• MDR Text Key: 317844721
• Report Number: 9610825-2023-00283
• 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
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• 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: 22G15GE561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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