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 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used, nearly empty easypump ii lt 270-27-s in open packaging.The provided sample was subjected to a visual inspection.As-received condition the clamp clip was closed and the patient connector was not blocked (the original wing cap was not handed over by the customer).After opening the big white top cap and removing the closing cone, we detected solution (liquid) at the filling port (lli-cone).In addition, we detected crystallized drug residues and solution (liquid) at the patient connector.Moreover, the pump was taken to a functional test respectively a leak test was carried out, therefore the pump was refilled with approximately 200 ml nacl 0.9 %.After starting the pump and waiting for 60 minutes the pump did work immediately (solution was running).After these 60 minutes leakages were not detected.In addition, the flow rate of the pump was tested.Nominal: 10 ml/h.Actual: 15.9 ml in 1h; 29.7 ml in 2 hrs and 116.7 ml in 12 hrs (44.44 % of the total running time).The inspected pump is neither blocked nor is the measured flow rate of the sample divergent from our requirement.Device history record (dhr): reviewed the device history record and there was no defect encountered during final control inspection.All available information has been forwarded to the actual manufacturer.If pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility ((b)(4)): pump-flow rate-too slow.

• 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: 6202089
• MDR Text Key: 63205185
• Report Number: 9610825-2016-00918
• 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
• Report Date: 12/23/2016,11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2016
• 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: 4540008
• Device Lot Number: 16F11GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/23/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2016
• Date Manufacturer Received: 11/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2016
• 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