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

Model Number N/A

Device Problem Inaccurate Flow Rate (1249)

Patient Problems Inflammation (1932); Irritation (1941)

Event Date 02/24/2015

Event Type  malfunction  

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.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): pump contained 4800 mg 5fu.It was filled with 96 ml (5fu) and 2 ml (nacl).The pump was empty in 24 hours in order to 49 h.Consequently : oral mucositis with irritation.Impossibility to feed with solid food during 15 days.

• Brand Name: EASYPUMP® II
• 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, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5493504
• MDR Text Key: 40125412
• Report Number: 9610825-2016-00085
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2016,03/12/2015

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: 05/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540016V
• Device Lot Number: 14F06GE261
• 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: 03/10/2016
• Distributor Facility Aware Date: 03/04/2016
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2016
• Initial Date Manufacturer Received: 03/12/2015
• Initial Date FDA Received: 03/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2014
• 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