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

Catalog Number 4540040-02

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: no flow, the pump was filled with diluent and was attempting to prime the line, but no fluid will move through the tubing.Line was unclamped.No injury reported.Sample available.

Manufacturer Narrative

(b)(4).Received one piece of used and filled easypump ii st 100-0,5-s-us without packaging.As received condition, clamp clip was not clamped and the original wing cap was attached to the pump.Complaint sample was tested for functional test, respectively leak test.The wing cap was removed.No flow was observed.The complaint sample was then left for 10 minutes.However, the pump remained not working.The sample was visually inspected under smart scope.Found that the connection between the triangle tube and the filter was blocked due to excess glue.Cause: failure in production process.Corrections/containment plans with effective date: customer complaint is shared with production to increase their awareness regarding the defect.Operators were re-training to sop elastomeric infusion system - final assembly process.Device history record (dhr): review of the device history records was performed and no non conformances or deviations were noted in process and final inspection.If additional pertinent information becomes available a follow-up report will be filed.

• 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
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun str.1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; b. braun melsungen ag; carl-braun str. 1; melsungen, 34212 ; GM 34212 ; 661712769
• MDR Report Key: 6042380
• MDR Text Key: 57931496
• Report Number: 9610825-2016-00658
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 12/19/2016,09/29/2016

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: 02/01/2021
• Device Catalogue Number: 4540040-02
• Device Lot Number: 16C20GE671
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2016
• Distributor Facility Aware Date: 09/29/2016
• Event Location: Other
• Date Report to Manufacturer: 12/19/2016
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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