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

Model Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported bd alaris pump module smartsite infusion set was damaged, resulting in leakage.The following information was provided by the initial reporter: "when checking the tubing there was air in the filter.The line/filter was cracked.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported bd alaris pump module smartsite infusion set was damaged, resulting in leakage.The following information was provided by the initial reporter: "when checking the tubing there was air in the filter.The line/filter was cracked.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evaluation? yes.D10: returned to manufacturer on: 2021-11-29 h6: investigation summary one sample was received for quality investigation.The customer complaint of component damage - crack with leak was partially verified by inspection.The infusion set was examined visually without a noticeable crack identified during the inspection.The infusion set was then primed and a leak was noted coming from one of the filter vents.A device history record review for model 2434-0007 lot number 20086789 was performed.The search showed that a total of (b)(4)units in 1 lot number was built on 15aug2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in the complaint is that the filter vents were over saturated with fluid and therefore causing the leakage past the vents.Similar issues seen in these filters are caused by the filter being over saturated with the infusion media causing the filter to clog and causing leakage out of the filter vents.The filter was sent to the supplier for further investigation of the component.

• 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: 13177703
• Report Number: 9616066-2022-00001
• Device Sequence Number: 19999871
• Product Code: FPA
• UDI-Device Identifier: 37613203019690
• UDI-Public: 37613203019690
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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 Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 03/22/2022
• 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