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

Catalog Number	10013902
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 extension set had connection issues.The following information was provided by the initial reporter: the patient has an iv remodulin infusion running through her port which requires a very specific dosage, including keeping it running continuously with no stopping.This medication also requires a 0.2 micron filter at the end of the infusion line.Upon getting the patient up to for the bathroom, we noticed that the 0.2 micron filter was disconnected from the patient, it had broken within the filter line, which caused an unknown amount of time the patient was disconnected from remodulin.Upon inspection the filter had snapped off.We subsequently reprimed a new filter with the remodulin and reconnected/restarted the medication.Was there injury? no, reached the individual but did not cause harm.
Additional Manufacturer Narrative
One sample was received.Examination of the sample shows separation of the tubing at the inlet port to the inline filter.The customer complaint of connection issue was not confirmed, but separation was identified.The investigation was forwarded to manufacturing for root cause analysis.After investigation, the possible root cause of separation between tubing-sleeve/filter is due to lack of solvent that could be related to issues with the pin used in the solvent dispenser.The failure mode was addressed under a work directive approved on september 06, 2024 to update standard working instructions to specify the correct pin to use for this assembly.No additional actions were taken since this product line has been deactivated at the manufacturing location of the sample provided.A device history record review for model 100136902 lot number 24059174, 24059175 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 EXTENSION 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23336380
• Report Number: 9616066-2025-03205
• Device Sequence Number: 9451963
• Product Code: FPA
• UDI-Device Identifier: 10885403233814
• UDI-Public: (01)10885403233814
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 01/19/2026

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: 10013902
• 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: 09/25/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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