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

Model Number	11522558
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using a bd alaris pump module smartsite infusion set there was component separation.This occurred 45 times.There was no report of patient impact.The following information was provided by the initial reporter: its detaching/coming loose in places.
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using a bd alaris pump module smartsite infusion set there was component separation.This occurred 45 times.There was no report of patient impact.The following information was provided by the initial reporter: its detaching/coming loose in places.
Additional Manufacturer Narrative
The following fields were updated due to additional information: h5: imdrf annex b grid b11, b14, b17.H5:imdrf annex c grid: c1601.H5: mdrf annex d grid: d03.Investigation summary: no photo or sample was received for the customer's complaint of separation leak.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.This failure type has been identified in other sets and has been due to a manufacturing deficiency that has since underwent corrective actions to prevent further separations of this set.A device history record review for model 11522558 lot number 22095036 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Additional Manufacturer Narrative
H6: investigation summary: no photo or sample was received for the customer's complaint of separation leak.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review for model 11522558 lot number 22095036 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported while using a bd alaris pump module smartsite infusion set there was component separation.This occurred 45 times.There was no report of patient impact.The following information was provided by the initial reporter: its detaching/coming loose in places.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16134012
• Report Number: 9616066-2022-02179
• Device Sequence Number: 3238716
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: (01)50885403232303
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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,Followup
• Report Date (Section B): 03/03/2023

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: 09/01/2025
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: 22095036
• 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: 12/21/2022
• Supplement Date Received by Manufacturer: 01/30/2023; 03/03/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 02/14/2023; 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• 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