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 Consequences Or Impact To Patient (2199)
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 event two of 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: event 2: the pump is leaking during filling / immediately after filling in an iso class 5 hood within an iso class 7 suite.The technicians noted it appears they may be cracked on the top and that they are leaking where they luer to the device to fill it with drug/diluent.The defect was noted when the technician attempted to add ganciclovir (cytotoxic agent).
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as event two of b.Braun medical inc.Internal report number (b)(4).One used pump was received for evaluation.The pump was visually inspected, and a crack was detected at the filling port which would have resulted in the leakage that was reported.A batch record review for the reported lot number did not reveal any abnormalities or non-conformances of this nature.In order to prevent further occurrences of this nature, the manufacturer has changed their inspection process to have 100% inspection for cracks at the filling port.They are also in the process of implementing new production machinery and evaluating how to optimize their production process for the filling port.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: 7344798
• Report Number: 9610825-2018-00031
• Device Sequence Number: 18842367
• 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: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018
• Report Date (Section F): 04/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2022
• Device Catalogue Number: 4540046-02
• Device Lot Number: 17K29GE701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/22/2018
• Device Age: 18 MO
• Date Report to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/19/2018
• 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: 04/19/2018