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 Underdose (2542)

Event Date 07/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Sample evaluation: received one used and filled with yellowish brownish colour solution easypump ii lt 270-27-s (batch no.Labeled 16e19ge221 / material no.(b)(4) on the big bottom cap of the sample) without original packaging.Examined the returned sample visually.Clamp clip was clamped.Patient connector (distal end) was not closed.Filling cap (discofix) was attached with filling port.The complaint sample was unclamped and observed the pump is working after 30 minutes (solution was running).Damages and cracks and leakages was not detected upon visual inspection at the distance of 25cm.Furthermore, the sample was subjected to leakage test according to test plan.The sample was originally filled with yellowish brownish solution to nominal volume 270ml<(>,<)> sample was dropped twice in one meter height<(>,<)> with positioning the sample once on its horizontal (axis), then perpendicular to its axis.The sample was immersed into a container with water at the end of the falling test for 5 minutes.The air filter is sealed.The sample is remained in watertight condition<(>,<)> and the water in the container has not become colored.Sample was found not leaking.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.However, slow flow rate is a known error pattern and corrective and preventive actions are in progress.

Event Description

As reported by the user facility (b)(6): slow flow.

• 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: 5908509
• MDR Text Key: 53294924
• Report Number: 9610825-2016-00854
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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
• Report Date: 08/26/2016,08/01/2016

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: 04/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540008
• Device Lot Number: 16E19GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2016
• Distributor Facility Aware Date: 08/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/26/2016
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/26/2016
• 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