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 10/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report has been identified as b.Braun (b)(4).The device is currently on shipping from (b)(4) for investigation.A follow-up report will be provided after the inspection results are available.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.

Event Description

As reported by the user facility (b)(4): fast flow of easypump.

Manufacturer Narrative

(b)(4).We received one used, empty easypump ii lt 125-25-s without packaging.The provided sample was taken to a visual inspection.As-received condition the clamp clip was closed and the patient connector was closed with a red closing cone.Damages or other deviations were not detected.After opening the big white top cap we detected crystallized drug residues and solution at the filling port (lli-cone) and crystallized drug residues at the patient connector (lla-cone) of the sample.In addition, the sample was taken to a functional test respectively a leak test was carried out.Therefore the pump was filled up to the nominal volume of 125 ml with nacl 0.9 %.After starting the pump and waiting for 60 minutes the pump did work immediately (solution was running immediately).After these 60 minutes leakages were not detected.Moreover, the flow rate of the pump was tested.Nominal: 5 ml/h.Actual: 8.4 ml in 1 h; 17.6 ml in 2 hrs; and 87.9 ml in 16 hrs.The decisive value to evaluate the flow rate will be measured approximately at the half of the pump running time.This value is within the specification at the tested sample.The flow rate of the inspected pump is accordance with our requirements.

• 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: 6053668
• MDR Text Key: 58307589
• Report Number: 9610825-2016-00679
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 02/03/2017,10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540006
• Device Lot Number: 16D12GE211
• 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: 10/07/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/12/2016
• 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