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

Model Number	10013364
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ secondary set tubing separated from the chemotherapy chamber and leaked chemo onto the floor.The following information was provided by the initial reporter: "so i went to the picu today to do anatoliy chemo.As i was back priming i could hear something spilling.The tubing came about from the chemo chamber and chemo was spilling onto the floor.".
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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 the bd alaris¿ smartsite¿ secondary set tubing separated from the chemotherapy chamber and leaked chemo onto the floor.The following information was provided by the initial reporter: "so i went to the picu today to do anatoliy chemo.As i was back priming i could hear something spilling.The tubing came about from the chemo chamber and chemo was spilling onto the floor.".
Event or Problem Description
It was reported that the bd alaris¿ smartsite¿ secondary set tubing separated from the chemotherapy chamber and leaked chemo onto the floor.The following information was provided by the initial reporter: "so i went to the picu today to do anatoliy chemo.As i was back priming i could hear something spilling.The tubing came about from the chemo chamber and chemo was spilling onto the floor.".
Additional Manufacturer Narrative
H6: investigation summary : one photo was provided by customer for investigation by our quality team.The photo was inspected and the separation was clearly presented.This verified the customer's complaint.Without further evidence like a physical sample, the root cause of this failure remains unknown.A device history record review for model 10013364 lot number 20077256 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10013364 lot number 21015483 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS¿ SMARTSITE¿ SECONDARY 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12844533
• Report Number: 9616066-2021-52452
• Device Sequence Number: 4350841
• Product Code: FPA
• UDI-Device Identifier: 50885403221925
• UDI-Public: 50885403221925
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 11/30/2021

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: 10013364
• Device Catalogue Number: 10013364
• 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: 10/25/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/21/2021
• 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