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 10/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used, empty easypump ii lt 270-27-s without packaging.The provided sample was subjected to a visual inspection.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).Damages or other deviations were not detected at the sample.After opening the big white top cap we detected solution at the filling port (lli-cone) and at the patient connector (lla-cone) of the sample.In addition, the sample was taken to a functional test respectively a leak test was carried out.Therefore the pump was filled up to the nominal volume of 270 ml with nacl 0.9 %.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: 10 ml/h.Actual: 14.1 ml in 1 h; 27.6 ml in 2 hrs; 187.7 ml in 19 hrs.The flow rate of the inspected pump is within our specifications.Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.All available information has been forwarded to the actual manufacturer.If additional pertinent information becomes available, a follow up report will be filed.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (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: 6202078
• MDR Text Key: 63202678
• Report Number: 9610825-2016-00916
• 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: 12/23/2016,11/30/2016

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: 16D01GE221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• 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
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 12/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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