MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ GRAVITY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	41173E
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an unspecified number of bd alaris¿ smartsite¿ gravity sets back-flowed during the infusion.The following information was provided by the initial reporter: "describe the event or problem: our iv tubing gravity administration set has been back flowing excessively on multiple patients over the last week.What was the original intended procedure? : iv fluids.What problem did the user have: device malfunction - that is, the device did not do what it was supposed to do".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Fda notified? the initial reporter also notified the fda via medwatch#: (b)(4).A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint of back flow as well as tubing falling apart could not be verified due to the product not being returned for failure investigation.Device history record review for model 41173e lot number 22069613 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
It was reported that an unspecified number of bd alaris¿ smartsite¿ gravity sets back-flowed during the infusion.The following information was provided by the initial reporter: "describe the event or problem: our iv tubing gravity administration set has been back flowing excessively on multiple patients over the last week.What was the original intended procedure? : iv fluids what problem did the user have: device malfunction - that is, the device did not do what it was supposed to do".

• Brand Name: BD ALARIS¿ SMARTSITE¿ GRAVITY 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: 16625104
• Report Number: 9616066-2023-00579
• Device Sequence Number: 5310419
• Product Code: FPA
• UDI-Device Identifier: 07613203020893
• UDI-Public: 07613203020893
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• 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): 04/10/2023

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 Catalogue Number: 41173E
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 04/16/2023
• 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