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

Catalog Number	42081E
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of connection issues and "lumen of the tubing is smaller" could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 42081e because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
Yes, we have had issues w/ the xxx spikes getting stuck in the units¿ ¿spike port¿ when switching out bags of plasma and red cells during apheresis procedures (no issues w/ using on albumin bottles).This was causing us to have to lose a nice amount of a unit because the spikes wouldn¿t come out and so tubing needed to be changed often.Apparently, this had happened frequently w/ this brand of tubing (xxx) which caused us to continue ordering xxx tubing, as we have no issues w/ spikes getting stuck w/ this brand.I have asked the nurses to attempt to use the xxx brand to see if the issue we had in the past has been resolved w/ these spikes.Many are apprehensive as they recall the issues from before.So far, one procedure has been completed w/o issue on plasma units¿ we will see if they work well w/ rbcs as well¿ and i guess we will go from there.If we can make xxx work, we will definitely use them, but if we run into the same complications w/ the spikes, we may need to resume the xxx tubing search.On (b)(6) 2025: the issues w/ bd blood tubing occurred a few years back when the system first trialed the bd tubing.At that time, d/t the difficulty in changing blood product units (spikes would get stuck) we as a department opted to continue using the baxter tubing.I have no information as to lot #¿s or images of the products from then.I will check our quality records to see if we have any identifying notes for this tubing set.The assumption was that the product now would do the same as the product then- and as of yet, this has not been the case.We have used the bd tubing for a little over a week with no issues and if this continues ¿ then there will be no need to revert to baxter.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Loss of exchange fluid when tubing had to be changed.

• Brand Name: ALARIS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23877127
• Report Number: 9616066-2025-03889
• Device Sequence Number: 21233713
• Product Code: FPA
• UDI-Device Identifier: 07613203020855
• UDI-Public: (01)07613203020855
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K882302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/10/2025

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: Health Professional
• Device Catalogue Number: 42081E
• 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: 11/26/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown