MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Catalog Number	362431
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is unknown if the device involved will be available for evaluation, 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 the user facility: a lab was being drawn on a patient and the iv needed to be stopped.When the nurse went to restart it, it was alarming.No one noticed what the alarm was for, an occlusion or air but the nurse turned it off so that she could return a short time later to resolve the issue.In the meantime another nurse went in to resolve the issue and found the tubing below the pump full of air.I have talked to multiple nurses and no one has any idea how air could have gotten into the line below the pump.According to the incident report the main bag had 950 mls in it and the cefazolin bag had 25 mls in it.The nurse did clamp the primary tubing above the pump when she turned it off but the secondary was unclamped and fluid in the bag.No patient injury.
Additional Manufacturer Narrative
(b)(4).As reported by the user facility, it was confirmed that the batch number was unknown and the sample was not available for evaluation.Without the actual device and/or lot number, a thorough investigation could not be performed.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: INFUSOMAT®
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• MDR Report Key: 7569147
• Report Number: 9614279-2018-00089
• Device Sequence Number: 1980236
• Product Code: FPA
• UDI-Device Identifier: 04046964294013
• UDI-Public: 04046964294013
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: Health Professional
• Device Catalogue Number: 362431
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1