MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. DEHPFREE PRI GRAV SET 1 SS VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	41173E
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	06/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.The initial reporter also notified the fda on 14 july, 2020.Medwatch report # mw5095273.Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that dehpfree pri grav set 1 ss vlv had air in the line which likely resulted in air embolism.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: 41173e, batch no: unknown.It was reported that ct of chest/abdomen/pelvis revealed likely a "iatrogenic embolism" in heart and pulmonary arterial trunk.Event description per email states: ct chest/abdomen/pelvis revealed likely iatrogenic air embolism in heart and pulmonary arterial trunk.This is the second similar event in a 2 month time frame that could be attributed to iv tubing.Bd currently has a recall on other iv tubing that can result in air embolism.Fda safety report id# (b)(4).
Event or Problem Description
It was reported that dehpfree pri grav set 1 ss vlv had air in the line which likely resulted in air embolism.This occurred on 2 occasions.The following information was provided by the initial reporter: material no: 41173e batch no: unknown.It was reported that ct of chest/abdomen/pelvis revealed likely a "iatrogenic embolism" in heart and pulmonary arterial trunk.Event description per email states: ct chest/abdomen/pelvis revealed likely iatrogenic air embolism in heart and pulmonary arterial trunk.This is the second similar event in a 2 month time frame that could be attributed to iv tubing.Bd currently has a recall on other iv tubing that can result in air embolism.Fda safety report id#(b)(4).
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.A device history record review could not be performed on model 41173e because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

• Brand Name: DEHPFREE PRI GRAV SET 1 SS VLV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10646213
• Report Number: 9616066-2020-20038
• Device Sequence Number: 2561882
• Product Code: FPA
• UDI-Device Identifier: 37613203020900
• UDI-Public: 37613203020900
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2020

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?: Yes
• Operator of Device: Other
• Device Model Number: 41173E
• Device Catalogue Number: 41173E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other