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

Catalog Number	20039E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Initial reporter facility name: (b)(6) hospital.Device evaluation: a 20039e product was not available for investigation of pr (b)(6); however, the customer provided lot number was incorrect.The feedback provided by the customer states that, "unable to bolus." no further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation; however, the lot number provided was incorrect and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the 20039e set in the past 12 months.
Event or Problem Description
It was reported that the bd alaris smartsite extension set was occluded.The following information was provided by the initial reporter: unable to bolus.
Additional Manufacturer Narrative
Investigation result: five 20039e samples were received without packaging for investigation.The feedback provided by the customer indicates that they were "unable to bolus".No further information was available regarding sequence of events leading to the customer's experience.A visual inspection of the returned samples confirmed that residual blood was present in four of the five returned samples; with three of the five containing residual blood throughout.Functional testing was performed by subjecting the products to a flush through using a 50ml bd plastipak syringe; an occlusion was observed with three of the samples filled with residual blood.No flow restriction or occlusion was observed throughout testing of the remaining two samples.The details of this feedback were forwarded to the manufacturing site for investigation.A definitive root cause for the customer's experience could not be identified, however as residual blood was present throughout the occluded sets, its unlikely that the customer's experience was as a result of a manufacturing defect; in this instance it is likely that the occlusions observed were as a result of the dried blood within the infusion line.A review of the reported lot number confirmed that it did not correspond to the reported product, and therefore it is not possible to perform a review of the production documentation for this particular product.Although it was not possible to determine a definitive root cause for the customer's experience, 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 a rare occurrence with a small number of similar reports against the 20039e set in the past 12 months.
Event or Problem Description
No additional information.

• Brand Name: ALARIS SMARTSITE
• 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: 22978766
• Report Number: 9616066-2025-02665
• Device Sequence Number: 13104133
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: (01)07613203011952(10)23035118
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: Other
• Device Catalogue Number: 20039E
• 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: 08/08/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/20/2025
• 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