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

Catalog Number 4540010

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is currently shipping from (b)(6) to bbm in (b)(6) for investigation.A follow up report will be provided after the inspection results are available.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by user facility (translation of user facility information by bbm sales in (b)(6)): under infusion.Drug: 5fu.

• Brand Name: EASYPUMP
• Type of Device: ELASTOMERIC INFUSION PUMP
• 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 ; 861 marcon blvd.; allentown, pa ; 2408332
• MDR Report Key: 5489410
• MDR Text Key: 191100134
• Report Number: 9610825-2015-00444
• Device Sequence Number: 1
• Product Code: MEB
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 4540010
• Device Lot Number: 14F16GE238
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2020
• Distributor Facility Aware Date: 09/23/2015
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2020
• Date Manufacturer Received: 09/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2014
• 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