MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. AS LVP 20D LOW SORB SS 0.2M; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	10010454-0006
Medical Device Problem Codes	Obstruction of Flow (2423); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported flow issues.Description: it was reported that the bd alaris infusion 0.2 filter set (item code: 10010454) currently in use in the fourth floor oncology unit is experiencing a significant functional issue.During infusion, the drip chamber repeatedly empties, allowing air to enter the infusion line.This results in frequent interruptions to the infusion process.During use was patient or user harmed? if yes, please explain - no could you please confirm the serial number of the defective product is (b)(6)? - confirmed please confirm the number of products affected.- multiple used from same batch number please confirm how the fault was identified? - observed by nurses please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? - about 15 minutes into the infusion please confirm the infusion set-up ¿ gravity or pump, height of infusion line, entry point to patient, infusion rate and pressure, infusion line set-up (other extensions or accessories) etc? - via pump which is placed in line with the patient, no extensions or accessories used.Multiple infusion rates and medications.Please provide details of the *type, size, and manufacturer of fluid container in use? *(i.E, is it a collapsible bag, a semi rigid plastic container or a glass bottle) - multiple if using a semi-rigid container or glass bottle, please confirm if the drip chamber air inlet vent was open or closed? (if open, when during the priming sequence was it opened?) - vent reported as open.Please confirm if the drip chamber air inlet had wetted out? - unable to confirm.Please confirm the make and model of the connecting product(s)? - n/a please confirm if there is any visible damage on the set ¿ such as cracks, flashes or deformation? - no visible damage.Please confirm what substance was being infused during the time of the event? - multiple but all oncology medications was there any patient harm? - none reported.Was there an under infusion? - yes did the pump alarm? - no was there any external leakage? - no what was being infused? - oncology medications, multiple was this issue identified during priming and set up? - no was the user present at the time of the event? - yes.
Additional Manufacturer Narrative
Correction: material number updated.See d tab.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
No 10010454-0006 sample was available for investigation.The customer reported that the affected samples were from lot 25025275 and that "during infusion, the drip chamber repeatedly empties, allowing air to enter the infusion line.This results in frequent interruptions to the infusion process." additional feedback from the customer noted that this occurs about 15 minutes into infusion with different infusion fluid containers, and that the air vents are opened.The details of this feedback were forwarded to the manufacturing site for investigation.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the production records for lot 25025275 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although it was not possible to determine a definite root cause for this issue, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 10010454-0006 product in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: AS LVP 20D LOW SORB SS 0.2M
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 24211301
• Report Number: 9616066-2026-00168
• Device Sequence Number: 20191442
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: (01)07613203015806
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2026

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: Health Professional
• Device Catalogue Number: 10010454-0006
• Device Lot Number: 25025275
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided; 02/27/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/26/2026; 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown