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

Model Number	621-400ESR
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device involved has not 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 reported by customer: on (b)(6) 2017 at approximately 4:30 am - patient and husband were in their room when room started to fill with smoke.They called for rn and the rn noticed that it was originating from the pump.Normal saline was running.Patient and husband were moved to another room.All vitals were stable, no visible harm, patient was anxious.Tubing was moved to a different pump.Pumps were taken to biomed.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).An investigation took place based on the picture provide.Per the event description, the reporter stated that two pumps were being used at the time of the reported event.The reporter stated that "one pump was plugged into a second pump.The grounding pin from the plug was broken off into the other pump".Although the pump was not returned, from the picture it was noted that there were several pumps connected and thermal damage was evident at the plug connection.From the picture of the plug, it could be seen that the prongs of the connection were not bent however, the ground pin on the electrical connection was missing.It should be noted that the ifu for the pump states "note: do not use a pump with visible damage or with bent, damaged, or missing components".Multiple attempts to obtain the pump and/or logs were not successful.Without the actual device further evaluation was not possible and no specific conclusion can be drawn.If the device and/or additional pertinent information is received this complaint will be reopened and the results added to the file.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: 6439543
• Report Number: 1641965-2017-00007
• Device Sequence Number: 10913452
• Product Code: FRN
• UDI-Device Identifier: 04046964186554
• UDI-Public: (01)04046964186554
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,other,use
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2017

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 Model Number: 621-400ESR
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: 03/15/2017
• Initial Report FDA Received Date: 03/28/2017
• Supplement Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1