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

Catalog Number	2204-0007
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter facility name: (b)(6) hospital.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris smartsite pump infusion set had a loose component.The following information was provided by the initial reporter: etoposide started leaking shortly after initiation today, and it looked to me like it originated from somewhere around the blue plastic piece in the line (circled below).There was a decent amount of liquid inside the pump channel and dripping out the bottom but everything from that blue plastic piece and upstream was dry.We pulled on a line, and it didn¿t take too much strength to detach the stretchy tubing from the bottom of the blue piece.The nurses said they have to stretch out that part to get it into the pump channel so this could just be user error but wanted to let you know in case this come up again.For what it¿s worth, the nurse said she¿s never seen a leak originate from there before.Additional information received from the customer: it is a chemotherapy drug.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm.
Additional Manufacturer Narrative
Two photos were received for quality evaluation.Examination of the two photos submitted indicate where the customer reported the loose component was located.One of the photos received shows a tubing set inserted into the alaris pump.An issue cannot be confirmed with that photo.The second photo shows an infusion set that is laid flat on the table.Close examination shows that the silicone tubing is missing the securement collar that holds the silicone tubing to the upper pumping segment fitting.The customer complaint of loose component was confirmed.After the investigation along with the manufacturing and quality operations team, the root cause of the leakage in the silicon tubing/upper fitment is the missing ring retainer due to an incorrect following assembly sequence by the production personnel.Improvements to the silicone segment process were implemented.The improvements include the following: update of the pumping chamber assembly procedure.Update the cleaning process for the pumping chamber machine.A device history record review for model 2204-0007 lot number 25075370 was performed.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 PUMP INFUSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23513828
• Report Number: 9616066-2025-03421
• Device Sequence Number: 9742305
• Product Code: FPA
• UDI-Device Identifier: 10885403199363
• UDI-Public: (01)10885403199363(17)280710(10)25075370
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 2204-0007
• Device Lot Number: 25075370
• 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: 10/20/2025
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown