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

Catalog Number	20029E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use with bd alaris¿ smartsite¿ extension set the device alarmed for occlusion.The following information was provided by the initial reporter: it was reported by customer that during the last 6 mls of kanuma infusing to patient, the pump began beeping for occlusion at patient side.Confirmed patency of port a cath by aspiration and flush.Then attempted to flush distal to smallbore tubing 0.2 micron low protein binding fliter needle-free valve.Determined occlusion was at the filter.Removed filter tubing and replaced.Infusion then completed without further occlusion.Faulty tubing sample saved.
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported that during use with bd alaris¿ smartsite¿ extension set the device alarmed for occlusion.The following information was provided by the initial reporter: it was reported by customer that during the last 6 mls of kanuma infusing to patient, the pump began beeping for occlusion at patient side.Confirmed patency of port a cath by aspiration and flush.Then attempted to flush distal to smallbore tubing 0.2 micron low protein binding fliter needle-free valve.Determined occlusion was at the filter.Removed filter tubing and replaced.Infusion then completed without further occlusion.Faulty tubing sample saved.
Additional Manufacturer Narrative
H.6.Investigation summary: one sample (model #20029e, lot #21096128) was returned by the customer.It was reported by customer that during the last 6 mls of kanuma infusing to patient, the pump began beeping for occlusion at patient side.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set were connected to a 10 ml bd syringe and attempted to be flushed with water.The set was able to be flushed with force, however, the filter was leaking and bubbles were flushing out the distal end.There were no signs of excess solvent.A quality notification was sent to the supplier of the filter.The supplier of the filter was able to confirm the failure.After the investigation, the root cause was determined to be that the hydrophobicity of the membrane was compromised, possibly due to the medications/fluids being used.A device history record review for model 20029e lot number 21096128 was performed.The search showed that a total of (b)(4).Units in 1 lot number was built on 27sep2021.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 h10.

• Brand Name: BD ALARIS¿ SMARTSITE¿ EXTENSION 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 ; 8448235433
• MDR Report Key: 17234674
• Report Number: 9616066-2023-01326
• Device Sequence Number: 12172994
• Product Code: FPA
• UDI-Device Identifier: 10885403234866
• UDI-Public: 10885403234866
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• 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): 10/16/2023

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 Catalogue Number: 20029E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 10/19/2023
• 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