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

Model Number N/A

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.Sample evaluation: received one used, empty easypump ii lt 270-27-s (batch no.Labeled (b)(4) /material no.4540008 on the big bottom cap of the sample).Examined the returned sample visually.Clamp clip was clamped.Patient connector (distal end) was not closed with the original closing cone (distal end cap), it was closed with a red stopcock.Filling cap (discofix) was attached with filling port.Sample was filled with normal saline solution to nominal volume 270 ml.The complaint sample was unclamped to prime the tubing and observed the pump did work after 30 minutes (solution was running).The definite cause and flow rate for the used sample will be comprehended in detail at production.Therefore, sample will forward to production for further investigation.A follow-up report will be provided after the inspection results are available.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): pump infused over 12 hours not 24.

Manufacturer Narrative

(b)(4).We received the following information after investigation at our manufacturing department: the flow rate test was passed at -13.76% deviation from nominal flow rate, which is within the spec of ±15%.However, flow rate deviation is a known error pattern and corrective and preventive actions are in progress / have been implemented.

• 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: jonathan severino ; 901 marcon blvd.; allentown 18109 ; 4847197287
• MDR Report Key: 6202063
• MDR Text Key: 63197712
• Report Number: 9610825-2016-00909
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2017,12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540008
• Device Lot Number: 16E19GE221
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2016
• 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