MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP® II; ELASTOMERIC INFUSION PUMP

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun (b)(4).This report has been identified as b.Braun (b)(4) internal report # (b)(4).We received 3 used and empty easypump ii lt 270-54-s without packaging.The received samples were taken to a visual inspection.In as-received condition the white clamp was missing at the 3 received samples.The original wing cap was not handed over by the customer, the patient connector was closed with a combi stopper at the 3 received samples.After opening the top cap we detected crystallized drug residues and residues of solution (liquid) at the filling port (lli-cone) and at the patient connector of the 3 received samples.Afterwards the 3 samples were filled up to the nominal volume of 270 ml with nacl 0.9 % and a functional test respectively a leak test was carried out.After opening the patient connector and waiting for 60 minutes the 3 pumps worked (solution was running).Furthermore we tested the flow rate of the 3 received samples.(b)(6).2 inspected samples are not within our specifications.The cause for the too fast flow at 2 received samples could not be find out.We have informed our manufacturer accordingly.A follow-up report will be provided after the statement is available.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): flow rate between 18.5 and 40 hours.

Manufacturer Narrative

(b)(4).Statement from manufacturer: according to bbm preliminary investigation, all complaint samples were flowing.However, flow rate of 2 returned samples were not within specification.As the complaint samples were contaminated with cytotoxic drug, further investigation is not possible.Therefore, the complaint is considered as not judgeable.However, flow rate deviation is a known issue and addressed in capa (b)(4).Blockage issue is addressed in capa (b)(4).Cause: failure in production process.

• 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: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5486996
• MDR Text Key: 40307154
• Report Number: 9610825-2016-00101
• Device Sequence Number: 1
• Product Code: MEB
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2016,02/18/2016

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: 06/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540018
• Device Lot Number: 15G06GE271
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/23/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2016
• Distributor Facility Aware Date: 02/18/2016
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/11/2016
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2015
• 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