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

Catalog Number 4540018-02

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Headache (1880)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: event 1; the infusion rate is supposed to be 48 to 54 hours, but it is only lasting 36 hours.The patient experienced headaches as a result of the over infusion.

Manufacturer Narrative

Exemption number e2016018.(b)(4).This report has been identified as event one of b.Braun medical inc.Internal report number (b)(4).Two (2) used devices were received for evaluation.The flow rate of both devices was checked over the course of 28 hours, and both pumps were within specification.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned device met requirements according to specification, and the reported failure could not be reproduced.Although the cause of the reported event could not be determined, it should be noted that the ifu for the product does indicate that the temperature of the surrounding environment will affect the flow rate of the device, and for every increase of 1 degree celsius the flow rate will increase by approximately 3%.The ifu also indicates that the flow restrictor of the product must be taped to the patient's skin in order to have proper flow.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7503974
• MDR Text Key: 108386708
• Report Number: 9610825-2018-00070
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 06/14/2018

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: 08/01/2021
• Device Catalogue Number: 4540018-02
• Device Lot Number: 16H02GE56R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2018
• Distributor Facility Aware Date: 04/13/2018
• Device Age: 2 YR
• Date Report to Manufacturer: 06/14/2018
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 04/13/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1