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 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received six used, filled with approx.50 ml easypump ii lt 270-27-s without packaging.The six provided samples were subjected to a visual inspection.Damages or manufacturing faults were not detected.As-received condition the clamp clips were closed and the patient connectors were closed with the original wing caps.After opening the big white top caps we detected solution at the filling ports (lli-cone) and at the patient connectors (lla-cone) of the samples.Additionally the six samples were filled with nacl 0.9 % up to the nominal volume (270 ml) and a functional test respectively a leak test was carried out.After waiting for a while the pumps did work (solution was running).Leakages were not detected at the samples.Furthermore, we tested the flow rate of the samples.Nominal: 10.0 ml/h.Actual: sample 1: 1.5 ml in 1 h; 2.6 ml in 2 hrs; 19.5 ml in 19 hrs, sample 2: 2.3 ml in 1 h; 5.0 ml in 2 hrs; 103.9 ml in 19 hrs, sample 3: 3.6 ml in 1 h; 10.0 ml in 2 hrs; 131.1 ml in 19 hrs, sample 4: 4.3 ml in 1 h; 10.3 ml in 2 hrs; 126.2 ml in 19 hrs, sample 5: 2.7 ml in 1 h; 5.5 ml in 2 hrs; 49.1 ml in 19 hrs, sample 6: 3.3 ml in 1 h; 11.4 ml in 2 hrs; 128.5 ml in 19 hrs.The inspected samples are not in accordance with our requirements.A follow-up report will be provided after the inspection results are available.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): easypumps were not empty after 24 hours.

Manufacturer Narrative

(b)(4).Device history records (dhr): reviewed device history records, there is no abnormalities and no such defect detected at final control inspection.

• 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: 6202081
• MDR Text Key: 63208296
• Report Number: 9610825-2016-00914
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 02/03/2017,12/01/2016

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?: Yes
• Date Returned to Manufacturer: 12/05/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Date Manufacturer Received: 12/01/2016
• 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