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

Catalog Number	11522558
Medical Device Problem Codes	Leak/Splash (1354); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd alaris pump module smartsite infusion set experienced component separation and leaked.The following information was provided by the initial reporter: reported issue: patient rolled over onto the tubing and tubing automatically disconnected at the y-site, chemo was stopped.Chemo spill and patient had a line break.
Additional Manufacturer Narrative
Investigation summary: no sample or photo was returned by the customer.The customer complaint of connection issue could not be verified due to the product not being returned for failure investigation.A device history record review for model 11522558 lot number 22085776 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 the bd alaris pump module smartsite infusion set experienced component separation and leaked.The following information was provided by the initial reporter: reported issue: patient rolled over onto the tubing and tubing automatically disconnected at the y-site, chemo was stopped.Chemo spill and patient had a line break.
Additional Manufacturer Narrative
It was reported by the customer that pt rolled over onto tubing and it automatically disconnected.One sample of material number 11522558 was received for quality investigation.Visual inspection of the sample shows that the sample separated at the outlet port of the y-site connector.Further inspection of the sample under magnification indicates that there is insufficient solvent at the outlet port of the y-site and the tubing, making separation of the tubing easier at that location.The customer complaint of connection issues was not confirmed, however, the sample showed that the tubing had separated from the y-site.Investigation at the manufacturing location indicates that the root cause for the failure is that the y-sties were found to have fluorosilicone on the surface in which the bonding solvent between the tubing and y-site body is located.The fluorosilicone does not let the solvent work properly leading to a weak engagement that generates gaps and separations between components.A trend for the reported issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the product and prevent future occurrences of this type.As part of the action plan, quality alerts were issued for the automation personnel regarding fluorosilicone inside the bonding pocket and to reinforce the flow test procedure.Additionally, updating documents regarding the calibration of the automated equipment, adding specification data for critical parts of the equipment and adding specification data for the critical parts that require calibration.Furthermore, preventative maintenance was added to the equipment used in the assembly, and additional equipment was purchased as a part of the corrective and preventative actions taken to correct the issue.A device history record review for model 11522558 lot number 22085776 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20aug2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
Event or Problem Description
Mat# 11522558; lot# 22085776.It was reported by the customer that pt rolled over onto tubing and it automatically disconnected.Verbatim: reported issue: patient rolled over onto the tubing and tubing automatically disconnected at the y-site, chemo was stopped.Chemo spill and patient had a line break.Chemo had to be remade and was hung up again.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16687043
• Report Number: 9616066-2023-00640
• Device Sequence Number: 20315982
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: (01)50885403232303
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/12/2023

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: Other
• Device Expiration Date: 08/20/2025
• Device Catalogue Number: 11522558
• Device Lot Number: 22085776
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 05/09/2023; 12/12/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/22/2023; 12/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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