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

Model Number	11426965
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
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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 bd alaris pump module smartsite infusion set components separated.There was no report of patient impact.The following information was provided by the initial reporter: during this incident, the iv infusion set was disconnected from the rest of the tubing above the loading chamber of alaris pump.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10-jan-2023.Investigation summary: the customer reported the tubing separated at the pumping segment, and returned a photo and the physical sample.The sample was clearly separated at the upper fitment and the complaint is verified.The root cause is traced to user error, the ring retainer was intact, and actually still attached to the silicon.The silicon tubing had torn in half and the remaining silicon was still attached under the ring retainer.Clinical was notified of the failure, and a discussion of the investigation found the root cause to be a potential use issue.Device history record review for model 11426965 lot number 22085660 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported while using bd alaris pump module smartsite infusion set components separated.There was no report of patient impact.The following information was provided by the initial reporter: during this incident, the iv infusion set was disconnected from the rest of the tubing above the loading chamber of alaris pump.

• 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: 16152950
• Report Number: 9616066-2022-02199
• Device Sequence Number: 7051609
• Product Code: FPA
• UDI-Device Identifier: 50885403232556
• UDI-Public: (01)50885403232556
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/15/2023

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 Model Number: 11426965
• Device Catalogue Number: 11426965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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