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

Catalog Number	4540058-02
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
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 b.Braun medical inc.Internal report number (b)(4) the actual device involved in the reported incident was not returned for evaluation.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.Although batch number 17e23ge511 was provided by the customer, this batch is not a valid batch for item 4540058-02 and as a result, a batch review could not be performed.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional pertinent information becomes available a follow-up report will be filed.
Event or Problem Description
As reported by user facility: vancomycin in nss infused over 6 hours when it was supposed to infuse over 24 hours.No patient injury.

• 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: 7952830
• Report Number: 9610825-2018-00215
• Device Sequence Number: 1190008
• Product Code: MEB
• UDI-Device Identifier: 04046964449239
• UDI-Public: (01)04046964449239
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/10/2018
• Report Date (Section F): 10/10/2018

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: Lay User/Patient
• Device Catalogue Number: 4540058-02
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/24/2018
• Event Location: Home
• Date Report to Manufacturer: 10/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Date Report Sent to FDA: 10/10/2018