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

Model Number	42493E
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 6 bd alaris smartsite gravity set experienced backflow.The following information was provided by the initial reporter: we have had 4 patients today between 7 am and 1pm using the iv tubing and blood is backing up all the way up to the bag with fluids in the bag still to be infused for no reason.
Event or Problem Description
It was reported that 6 bd alaris smartsite gravity set experienced backflow.The following information was provided by the initial reporter: we have had 4 patients today between 7 am and 1pm using the iv tubing and blood is backing up all the way up to the bag with fluids in the bag still to be infused for no reason.
Additional Manufacturer Narrative
H6: investigation summary: 17 unused sample model 42493e were returned for investigation.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with normal saline and attached to a bd secondary set primed with blue dye water.The sets were allowed to flow.No instance of backflow was observed.The customer complaint that the blood is backing into the bag could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 42493e lot number 22019204 was performed.The search showed that a total of 7203 units in 1 lot number was built on (b)(6) 2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

• 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 ; 8015296192
• MDR Report Key: 14515885
• Report Number: 9616066-2022-00667
• Device Sequence Number: 6466321
• Product Code: FPA
• UDI-Device Identifier: 10885403235375
• UDI-Public: 10885403235375
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/19/2022

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: Other
• Device Expiration Date: 01/10/2025
• Device Model Number: 42493E
• Device Catalogue Number: 42493E
• Device Lot Number: 22019204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 09/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2022
• 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