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 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one used and empty easypump ii lt 270-54-s without packaging.The received pump was taken to a visual inspection.As-received condition the white clamp was closed and the patient connector was not closed, the original wing cap was not handed over from the customer.Damages that would lead to a malfunction were not detected at the sample.After opening the 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 worked immediately (solution was running).Leakages were not detected.Furthermore the flow rate of the pump was tested.Nominal: 5 ml/h.Actual: 8.8 ml in 1 h; 16.7 ml in 2 hrs; 152,1 ml in 28 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.

Event Description

As reported by the user facility (b)(6): overinfusion.

• 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: 6368466
• MDR Text Key: 68772325
• Report Number: 9610825-2017-00042
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638(17)200601(10)15G06GE271
• Combination Product (y/n): N
• Reporter Country Code: BU
• 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: 03/01/2017,02/03/2017

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: 06/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540018
• Device Lot Number: 15G06GE271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/01/2017
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2015
• 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