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

Catalog Number	2477-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: no product or photo was returned by the customer.The customer complaint of flow issues - back flow 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 2477-0007 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
It was reported that the bd alaris smartsite pump infusion set had flow issues.The following information was provided by the initial reporter: rn was completing infusion rate verification during the idc process with primary rn for prbc transfusion when primary rn noted that blood was back flowing into second spike that was clamped while priming tubing, this rn watched the rn confirm the clamp was fully engaged, this rn was also present in the room during tubing priming and observed the clamp being placed.Both rns began the transfusion and watched to see if more blood would back flow into second spike.Blood did continue to back flow.Rn switched blood tubing, moved clamp lower on second spike.Transfusion continued without and further issues.Rn did note that both the first set of tubing that back flowed and second set of tubing that did not have any issues had the same lot number.Product: alaris pump tubing wd #: (b)(4) - tubing blood administration 100in smartsite 15 gtt/ml 180um mfg#: 2477-0007 lot#: n/a patient harm: no harm evident, physical or otherwise.

• 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.; 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: 25717265
• Report Number: 9616066-2026-01704
• Device Sequence Number: 16101646
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: (01)07613203019460
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 2477-0007
• 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: 06/11/2026
• Initial Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown