MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG B. BRAUN; 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
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.Additional attempts to receive the sample are being made.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: plastic was melting.
Additional Manufacturer Narrative
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, however photos were provided for evaluation.The pictures that were provided did show that there was a substance on the outside of the powercord, however they did not have enough detail to make any conclusions regarding thermal damage.Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: B. BRAUN
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 9112502
• Report Number: 9610825-2019-00428
• Device Sequence Number: 1782306
• Product Code: FRN
• UDI-Device Identifier: 04046964085673
• UDI-Public: (01)04046964085673
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142596
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2019

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?: No
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1