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 03/04/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used, half filled 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 not closed (the original wing cap was not handed over by the customer).Further on, we detected no liquid and crystallized drug residues at the filling port (lli-cone) and at the patient connector (lla-cone) of the sample.Additionally the pump was filled with nacl 0.9 % up to the nominal value (125 ml) and a functional test respectively a leak test was carried out.After starting the pump the pump did work immediately (solution was running).Leakages were not detected.Furthermore the flow rate of the pump was tested.Nominal: 5 ml/h.Actual: 7.8 ml in 1 h; 14.9 ml in 2 hrs; 83.8 ml in 16 hrs.The flow rate of the inspected pump is within our specifications.A too fast flow (as described by the customer) could not be determined.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

(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 ; 901 marcon blvd.; allentown 18109 ; 4847197287
• MDR Report Key: 6454000
• MDR Text Key: 71628862
• Report Number: 9610825-2017-00064
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448454
• UDI-Public: (01)04046964448454(17)210501(10)16F14GE211
• 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
• Report Date: 04/03/2017,03/06/2017

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: 05/01/2021
• Device Model Number: N/A
• Device Catalogue Number: 4540006
• Device Lot Number: 16F14GE211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2017
• Initial Date Manufacturer Received: 03/06/2017
• Initial Date FDA Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2016
• 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