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

Catalog Number	8713112D
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.The device has been forwarded to b.Braun melsungen ag (manufacturer) to complete the investigation.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
The power supply was originally reported as damaged.Once the power supply was received by b.Braun inc.(bbmi) (importer), it was visually inspected and it was discovered that the power supply exhibited signs of thermal damage.
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 used power supply was received for evaluation, and during the initial visual examination it was discovered that the power supply exhibited signs of thermal damage.Upon further evaluation, it was determined that the pins onthe primary adaptor were damaged in a way that caused them to lose connection with the board inside the power supply.The loose connection between the pins and the internal board of the power supply caused the thermal damage.Based on the condition of the power supply when it was received, the cause of the disconnection was most likely the result of the power supply being dropped several times.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.If additional information becomes available, a follow up report will be submitted.

• Brand Name: B. BRAUN
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 8154853
• Report Number: 9610825-2018-00259
• Device Sequence Number: 2325131
• Product Code: MRZ
• UDI-Device Identifier: 04046964085673
• UDI-Public: (01)04046964085673
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2019
• Report Date (Section F): 01/29/2019

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 Catalogue Number: 8713112D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/30/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 11/30/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 12/12/2018
• Supplement Report FDA Received Date: 01/29/2019
• 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: 01/29/2019