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

Catalog Number 4540018

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

As reported by the user facility ((b)(4)): fast flow.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).No sample has been returned for investigation.Without the actual sample, a thorough investigation could not be performed and no specific conclusion can be drawn as to the cause of the reported event.If the sample and/or additional pertinent information becomes available, a follow up report will be submitted.We have informed our manufacturer accordingly.Reviewed the device history record and no abnormalities found during in process and final control inspection.

• Brand Name: EASYPUMP II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str.1; melsungen 3421 2; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str.1; melsungen D-342-12 ; GM D-34212 ; 661712769
• MDR Report Key: 4586511
• MDR Text Key: 5449453
• Report Number: 9610825-2015-00063
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/22/2015,02/18/2015

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: 4540018
• Device Lot Number: 14F19GE272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2015
• Distributor Facility Aware Date: 03/02/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/22/2015
• Initial Date Manufacturer Received: 02/18/2015
• Initial Date FDA Received: 03/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2014
• 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