MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010453
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd alaris pump module smartsite low sorbing infusion set air was discovered in line just as it was reaching patient, alarm was not sounding.Information about potential patient impact has not been received.The following information was provided by the initial reporter: ¿i need help with getting a hold of a representative that can do some testing of a line and filter.This is for a bd alaris pump infusion set 1.2-micron filter ref (b)(4) that had air in the line below the filter.The in the line was noted by the bedside rn, just as it was reaching the patient.The alarm from the pump was not sounding (this was sequestered).We want to see if there was something wrong with the line or filter.¿.
Additional Manufacturer Narrative
Investigation summary no product or photo was returned by the customer.It was reported by the customer that the reported issue of a bd alaris pump infusion set 1.2-micron filter ref 10010453 had air in the line below the filter." the customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 10010453 because a lot number is unknown.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that during use with bd alaris pump module smartsite low sorbing infusion set air was discovered in line just as it was reaching patient, alarm was not sounding.Information about potential patient impact has not been received.The following information was provided by the initial reporter: ¿i need help with getting a hold of a representative that can do some testing of a line and filter.This is for a bd alaris pump infusion set 1.2-micron filter ref (b)(4).That had air in the line below the filter.The in the line was noted by the bedside rn, just as it was reaching the patient.The alarm from the pump was not sounding (this was sequestered).We want to see if there was something wrong with the line or filter.¿.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17234686
• Report Number: 9616066-2023-01329
• Device Sequence Number: 5806387
• Product Code: FPA
• UDI-Device Identifier: 37613203021143
• UDI-Public: (01)37613203021143
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/19/2023

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: 10010453
• Device Catalogue Number: 10010453
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 07/19/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown