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 Skin Irritation (2076)

Event Date 06/30/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun melsungen ag internal report # (b)(4) we received one used, empty easypump ii st 400-4-s without packaging.The provided sample was subjected to a visual examination.After opening the big white top cap and removing the closing cone, we detected solution (liquid) at the filling port (lli-cone).Furthermore we detected a crack in the li-cone of the filling port.Moreover, the pump was taken to a functional test respectively to a leak test.Therefore the pump was refilled with approximately 400 ml nacl 0.9 %.After starting the pump and waiting for 60 minutes the pump did work immediately.After these 60 minutes leakages were not detected.In addition, the flow rate of the pump was tested.Nominal: 100 ml/h.Actual: 145.6 ml in 1h; 271.6 ml in 2 hrs and 380.0 ml in 3 hrs (75 % of the total running time).With regard to the flow rate the inspected pump is not in accordance with our requirements as well with regard to the crack in the filling port.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected during in process and at final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): pump-flow rate-fast.

• 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 ; 200 boulder dr.; breinigsville, PA 18031 ; 4842408332
• MDR Report Key: 6762256
• MDR Text Key: 81694072
• Report Number: 9610825-2017-00153
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964449239
• UDI-Public: (01)04046964449239(17)211101(10)16N22GE471
• Combination Product (y/n): N
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 08/02/2017,07/04/2017

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: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540058
• Device Lot Number: 16N22GE471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2017
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2017
• Initial Date Manufacturer Received: 07/04/2017
• Initial Date FDA Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• 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