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

Catalog Number	24600-0007
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2025
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 pump infusion set had blood backflow.The following information was provided by the initial reporter: the iv tubing had blood backed up half the length of the tubing although it was still infusing.When i checked the line i found that the chemo bag (cytarabine) was infused and that roughly half of the primary bag having been infused as well, almost as if the pump was pulling from both lines.This was near the tail end of the infusion with only 30 mls approx remaining.By the time i came back to take the line down the remainder of the blood in the tubing had reinfused into the patient.At the time the pt said they had only been to the bathroom.There was no leakage present around the patient area nor did the patient say the line read any error while i was on break.Additional information received from the customer: can you please provide an exact date of event in this format mm-dd-yyyy? 06-13-2025 describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No negative outcome to the patient has been reported.
Additional Manufacturer Narrative
One sample of primary infusion set a one sample of a secondary infusion set were submitted for quality evaluation.Visual examination of the samples did not indicate any damages or abnormalities.The infusion sets were primed and connected to each other.A simulated infusion was conducted at 125 ml/hr for 1 hour.There were no issues with leakage, occlusion, air-in-line or flow.The customer complaint that blood backing up into the line could not be replicated.A root cause was not established because the reported issue could not be replicated.A device history record review for model 24600-0007 lot number 25025274 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22575974
• Report Number: 9616066-2025-02109
• Device Sequence Number: 9699966
• Product Code: FPA
• UDI-Device Identifier: 10885403241970
• UDI-Public: (01)10885403241970(10)25025274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 24600-0007
• Device Lot Number: 25025274
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/29/2025
• 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