MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. OUTLOOK®; PUMP, INFUSION

Model Number	621-400ES
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has been received for evaluation and the investigation is ongoing at this time.A follow-up will be submitted when the investigation results become available.
Event or Problem Description
As per reported by the user facility: a patient called out to state her iv pump was making a strange noise and she saw smoke and smelled a burning smell coming from the iv pump machine.It was reported a small fire was noticed in the load set area of the iv pump.No patient injury.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The device involved was received for evaluation.The initial inspections confirmed that the door cable showed evidence of a thermal event with charring on both the inside and outside areas of the cable boot.The device was plugged in and powered on for a physical evaluation.The device provided audible indication of a power up sequence to an alarm state but no visible output from the display.An operations log was successfully downloaded from the device.The device was then disassembled.It was observed that the entire main bezel assembly is an "ivt recertified" replacement.It was also observed there was no evidence of rtv that seals the door cable to the cosmetic bezel.This allowed for a fair amount of fluid intrusion.Further disassembly revealed that the key panel, cosmetic bezel, case top and nicad battery on the main board have been manufactured by a 3rd party.As the bezel assembly was removed from the device, it was noted that the main bezel assembly had no emi gasket installed.This gasket is intended to reduce radiation of electromagnetic interference created from within the device.Under magnification, dents were observed in the ribbon cable boot that may be indicative of a foreign object causing a puncture in the ribbon cable assembly upon closing the door.After removing the door cable from the bezel, two wires from the ribbon cable have been completely severed.In the ribbon cable, pin 1 of the ribbon cable marked with a red stripe.The second wire, or pin 2, is vcc and supplies 16vdc to the display board.After de-construction and visual inspection, the damaged door cable alone was replaced.The device was plugged-in to observe battery charging.No abnormal conditions were observed and subsequently, volumetric testing was performed at multiple rates with results meeting expected performance criteria.Based on the operations log data, physical evaluation and observations summarized, it has been determined that the thermal event is a result of compromised wires either once severed coming into contact with one another or coupled through potential fluid ingress.This is likely caused by inadequate pump servicing according to the outlook es service manual.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: OUTLOOK®
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive, suite 150; carrollton TX 75006 6690
• MDR Report Key: 9601062
• Report Number: 1641965-2019-00016
• Device Sequence Number: 10888437
• Product Code: FRN
• UDI-Device Identifier: 04046964186547
• UDI-Public: (01)04046964186547
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K011975
• 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,Followup
• Report Date (Section B): 02/07/2020

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: No Information
• Device Model Number: 621-400ES
• Device Catalogue Number: 621-400ES
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/17/2020
• Supplement Report FDA Received Date: 02/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1