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

Catalog Number	4540046-02
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number e2016018 b.Braun inc.(bbmi) (importer) is submitting the report on behalf of b.Braun melsungen ag (manufacturer).This report has been identified as b.Braun medical inc.Internal report number (b)(4) the investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: leaking from filter.Pump contained ganciclovir.Leakage was noticed right after patient opened clamp.Patients are taught to wear gloves when starting this medication so potential exposure is limited as patient noted leak immediately.No patient injury reported.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).One (1) sample was received for evaluation.The sample was visually and functionally inspected.Upon functional inspection, the device exhibited leakage at the welded area of the filter.B.Braun is working with the supplier of the filter to address issues with leakage from the filter.If additional information becomes available, a follow up report will be submitted.

• Brand Name: EASYPUMP
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 7429304
• Report Number: 9610825-2018-00053
• Device Sequence Number: 19346145
• Product Code: MEB
• UDI-Device Identifier: 04046964449031
• UDI-Public: (01)04046964449031
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018
• Report Date (Section F): 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/01/2022
• Device Catalogue Number: 4540046-02
• Device Lot Number: 17N04GE702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/19/2018
• Device Age: 4 MO
• Event Location: Home
• Date Report to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 05/29/2018