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

Catalog Number	11448964
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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¿ secondary set came apart where the tubing and chamber connected and spilled out gemcitabine over the table and pharmacist.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "two tubing sets: ref# (b)(4), and the secondary sets with the texium closed set, ref#(b)(4), have been leaking or coming apart at where the chamber and the tubing are supposed to be sealed together.Yesterday, we had a set come apart and leak gemcitabine all across the table in the cleanroom.Customer is looking to see if other facilities are having issues or what the cause could be.Both issues occurred separately.The set with the texium attached to it, ref# (b)(4), did fall apart and the chemo that was in it came in contact with one of our pharmacists from the waist down.Fortunately, no medical intervention was required.We do have a set, ref# (b)(4), that fell apart before we even attached it to the bag.We also have two bags with the fluid chamber connected to the bag, but the tubing had come apart.".
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 03-mar-2023.H.6.Investigation summary: two samples were received with the customer's complaint of separation.This investigation concerns the verified complaint of (b)(4) drip chamber separation.Pr (b)(4) will contain the investigation for the other separation in the pump segment upper fitment received.) only a drip chamber was received with the separation complaint but the information is sufficient for the root cause of insufficient solvent during assembly to be determined.The manufacturer is aware of this issue and is making active efforts to eliminate further occurrences of drip chamber separation with this set.A trend for the drip separation issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the 11448964 device and prevent future occurrences of this type.As part of the action plan, changes to the drip chamber to tubing assembly are in the process of being implemented.Customer complaint trends will also continue to be evaluated on a monthly basis.A device history record review for model 11448964 lot number 22119307 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17nov2022.There were no quality notifications issued for the failure mode reported by the customer during the 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.
Event or Problem Description
It was reported that the bd alaris¿ secondary set came apart where the tubing and chamber connected and spilled out gemcitabine over the table and pharmacist.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "two tubing sets: ref# (b)(4), and the secondary sets with the texium closed set, ref# (b)(4), have been leaking or coming apart at where the chamber and the tubing are supposed to be sealed together.Yesterday, we had a set come apart and leak gemcitabine all across the table in the cleanroom.Customer is looking to see if other facilities are having issues or what the cause could be.Both issues occurred separately.The set with the texium attached to it, ref# (b)(4), did fall apart and the chemo that was in it came in contact with one of our pharmacists from the waist down.Fortunately, no medical intervention was required.We do have a set, ref# (b)(4), that fell apart before we even attached it to the bag.We also have two bags with the fluid chamber connected to the bag, but the tubing had come apart.".

• Brand Name: BD ALARIS¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16615074
• Report Number: 9616066-2023-00557
• Device Sequence Number: 6254876
• Product Code: FPA
• UDI-Device Identifier: 10885403234743
• UDI-Public: 10885403234743
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/14/2023

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: 05/19/2025
• Device Catalogue Number: 11448964
• Device Lot Number: 22053234
• 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: 03/03/2023
• Supplement Date Received by Manufacturer: 04/14/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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