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 Type  malfunction  

Manufacturer Narrative

(b)(4).We received two used, empty easypump ii lt 125-25-s without packaging.The provided samples were subjected to a visual examination.As-received condition the clamp clips were closed and the patient connectors were closed with a red combi stopper (the original wing cap was not handed over by the customer).Damages or other deviations were not detected.At the samples we detected crystallized drug residues at the filling port (lli-cone).Solution or crystallized drug residues in the lla-cone were not detected.Afterwards the pumps were 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 pumps the pumps did work immediately (solution was running).Leakages were not detected.In addition the flow rate of the pumps were tested.Nominal: 5 ml/h.Actual: sample 1: 7.4 ml in 1 h; 13.1 ml in 2 hrs; 90.3 ml in 18 hrs.Sample 2: 4.9 ml in 1 h; 10.0 ml in 2 hrs; 85.4 ml in 18 hrs.The values are within the specification.A fast flow (as described by the customer) could not be determined at the inspected samples.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

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): fast flow.

• 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: 6440627
• MDR Text Key: 71103045
• Report Number: 9610825-2017-00058
• 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: GM
• 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: 03/28/2017,02/28/2017

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: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/28/2017
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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