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

Catalog Number 4540016

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): pump-flow rate-fast.Fast flow/infusion finished after 36 hours.

Manufacturer Narrative

(b)(4).The device is currently shipping from the customer to (b)(4) for investigation.A f/u report will be provided when the inspection results becomes available.(b)(4).

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(6).No sample has been returned for investigation.Without the actual device, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reproted event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.We have informed our manufacturer accordingly.Reveiwed the device history record (dhr) and there were no defects encountered during in process and final control inspection.Note: this follow up mdr is being submitted retrospectively due to a filing error by b.Braun medical inc.At the time of the reporting.At the time of initial reporting, exemption e2011009 applied to the case.

• Brand Name: EASYPUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 34212 ; GM 34212
• MDR Report Key: 4586497
• MDR Text Key: 5448950
• Report Number: 9610825-2015-00061
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• 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,company representati
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2015,07/20/2020

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 Expiration Date: 06/01/2019
• Device Catalogue Number: 4540016
• Device Lot Number: 14F24GE261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Distributor Facility Aware Date: 03/02/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2015
• Initial Date Manufacturer Received: 02/11/2014
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: 02/11/2014
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1