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

Catalog Number	4540058-02
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2018
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 end user : pump was taking a long time to infuse so the patient called the nurse to check it and when the easy pump was disconnected from the patient's port there seemed to be a hard piece present.The pump was filled with 900mg/300ml of rifampin.No patient injury.
Additional Manufacturer Narrative
Exemption number e2016018.(b)(4).This report has been identified as b.Braun medical inc.Internal report number (b)(4).One used device was received for evaluation.Upon visual inspection, no damage that would lead to a malfunction was observed, however crystallized drug residue was present within the device.No foreign matter was present in the device.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.A potential root cause of the slow flow rate is the crystallized drug that was present on th device.If additional pertinent information becomes available a follow-up report will be filed.

• 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: 7307311
• Report Number: 9610825-2018-00006
• Device Sequence Number: 1250092
• Product Code: MEB
• UDI-Device Identifier: 04046964449239
• UDI-Public: (01)04046964449239
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2018
• Report Date (Section F): 03/23/2018

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: Nurse
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 4540058-02
• Device Lot Number: 17E03GE761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/06/2018
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 03/23/2018
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 03/23/2018
• 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: 03/23/2018