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 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used, empty easypump ii lt 125-25-s without packaging.The provided sample was subjected to a visual inspection.Damages were not detected.As-received condition the clamp clip was closed and the patient connector was closed with a red combi stopper.Damages that would lead to a malfunction were not detected at the sample.Further on, we detected crystallized drug residues at the filling port (lli-cone) and at the patient connector (lla-cone) of the sample.Afterwards the provided pump was subjected to a functional test.After starting the pump and waiting for 60 minutes the pump did not work (solution was not running).After these 60 minutes leakages were not detected.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.

Event Description

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

Manufacturer Narrative

(b)(4).Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.We have informed our manufacturer accordingly.None new and pertinent information/results are available since the sample was duly investigated by bbm preliminary examination.

• 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 ; 901 marcon blvd.; allentown 18109 ; 4847197287
• MDR Report Key: 6202064
• MDR Text Key: 63205797
• Report Number: 9610825-2016-00908
• 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: 02/03/2017,12/08/2016

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: 4540006
• Device Lot Number: 16E03GE211
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/21/2016
• 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: 12/08/2016
• Initial Date FDA Received: 12/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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