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 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is currently on shipping from france to bbm in germany 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 (translation of user facility information by bbm sales organization in (b)(4)): pump-flow rate-fast.

Manufacturer Narrative

(b)(4).We received one easypump ii lt 270-27-s in original packaging.The provided sample was subjected to a visual inspection.Damages or manufacturing faults were not detected.Additionally the sample was filled with nacl 0.9 % up to the nominal volume (270 ml) and a functional test respectively a leak test was carried out.After waiting for a while the pump did work (solution was running).Leakages were not detected at the sample.Furthermore, we tested the flow rate of the sample.Nominal: 10.0 ml/h.Actual: 16.0 ml in 1 h; 30.5 ml in 2 hrs; 178.9 ml in 18 hrs.The flow rate of the sample is within our specifications.Leaks were not detected at the sample.A too fast flow (as described by the customer) could not be determined.

• 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: 6131367
• MDR Text Key: 60995752
• Report Number: 9610825-2016-00836
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/03/2017,11/02/2016

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: 03/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540008
• Device Lot Number: 16D08GE221
• 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
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• 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