MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP® II; ELASTOMERIC INFUSION PUMP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used and empty easypump ii lt 270-54-s without packaging.The received sample was taken to a visual inspection.In as-received condition the white clamp was missing.The original wing cap was not handed over by the customer, the patient connector was closed with a combi stopper.After opening the top cap we detected crystallized drug residues and residues of solution (liquid) at the filling port (lli-cone) and at the patient connector.Afterwards the sample was filled up to the nominal volume of 270 ml with nacl 0.9 % and a functional test respectively a leak test was carried out.After opening the patient connector and waiting for 60 minutes the pump worked (solution was running).Furthermore we tested the flow rate of the received sample.Nominal: 5 ml/h; actual: 8.2 ml in 1 h; 14.8 ml in 2 hrs and 130.1 ml in 25 hrs.A fast flow (as described by the customer) could not be determined.The inspected sample is within our specifications.Hence we assess this complaint to be not justified.We have informed our manufacturer accordingly.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): flow rate between 18.5 and 40 hours.

• 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: 5487008
• MDR Text Key: 40208484
• Report Number: 9610825-2016-00102
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2016,02/18/2016

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: 02/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540018
• Device Lot Number: 15C24GE27R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2016
• Distributor Facility Aware Date: 02/18/2016
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2016
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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