MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; 1000ML,PRESSURE INFUSER W/STOPCOCK

Model Number	DYNJAAPI1000S
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer contact, on (b)(6) 2023 a patient suddenly became short of breath with o2 sat of 74%.It was noted that the iv fluid bag that had been running with a pressure bag was empty and "full of air, throughout the entire line".The customer contact reported all lines were primed and air was removed from fluid bag before use.The customer reported due to the event a rapid response was called and the patient stabilized in 10 minutes.The sample was requested to be returned for evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Air emboli.

• Brand Name: Medline
• Common Device Name: 1000ML,PRESSURE INFUSER W/STOPCOCK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16939944
• Report Number: 1417592-2023-00218
• Device Sequence Number: 7205748
• Product Code: KZD
• UDI-Device Identifier: 10080196759620
• UDI-Public: 10080196759620
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYNJAAPI1000S
• Device Catalogue Number: DYNJAAPI1000S
• Device Lot Number: 65122110001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown