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 Information (3190)

Event Date 09/12/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is currently on shipping from colombia to bbm in germany for investigation.A follow-up report will be provided after the inspection results are available.

Event Description

(b)(4): infusion therapy just too slow.

Manufacturer Narrative

(b)(4).We received one used, nearly empty easypump ii lt 270-54-s without packaging.Additionally we received a disposable hypodermic needle (21 g, of a competitor) which is connected with the pump.The provided pump was subjected to a visual examination.As-received condition the clamp clip was closed and the patient connector was closed with the original wing cap.After opening the big white top cap and removing the closing cone, we detected solution (liquid) at the filling port (lli-cone).In addition, we detected solution (liquid) at the patient connector/original wing cap.Furthermore we detected a crack in the li-cone of the filling port.Moreover, the sample was taken to a functional test respectively to a leak test.Therefore the pump was refilled with approximately 150 ml aqua ad iniectabilia braun.After starting the pump (opening the clamp clip) and waiting for 60 minutes the sample did work immediately (solution was running).After these 60 minutes leakages were not detected.In addition, the flow rate of the pump was tested.Nominal: 5 ml/h.Actual: 6.1 ml in 1h; 12.0 ml in 2 hrs and 54.1 ml in 27 hrs (50 % of the total running time).The flow rate of the inspected pump is not in accordance with our requirements.The crack in the li-cone of the filling port is not in accordance with our requirements, too.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.However, flow rate deviation and crack at filling port 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 6081817
• MDR Text Key: 59456670
• Report Number: 9610825-2016-00701
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 02/03/2017,10/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540018
• Device Lot Number: 15D20GE271
• Was Device Available for Evaluation?: Yes
• 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: 10/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2015
• 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