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

Catalog Number	10010453
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2025
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 damaged / defective tubing.The following information was provided by the initial reporter: upon infusing a tpn for 2 separate patients on (b)(6), the tubing ripped open near the blue filter portion, allowing medication to leak out and blood return back to the tubing.In both cases, the tubing was exchanged.Different nurses administered the medication for both patients, so the tubing sets appeared to be faulty.The affected lot was removed from stock and will not be used for patient care.This impacted patient care as patient's tpns were stopped and not fully administered, impacting patient nutrition and medication administration.Product code: 10010453.
Additional Manufacturer Narrative
Forty-four samples were received for quality evaluation.Visual inspection of the samples was conducted and there were no damages or abnormalities.The samples were then primed and a simulated infusion was conducted at a rate of 125 ml/hr for 1 hour.Special attention was given to the tubing to filter connection to determine if there were any signs of leaks or damage during the infusion and normal handling of the samples.There was no leakage, air-in-line, flow issues, or occlusion identified during the testing.The customer complaint of leakage could not be confirmed.A root cause analysis was not conducted because the reported failure was not replicated.A device history record review for model 10010453 lot number 25055569 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.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23623641
• Report Number: 9616066-2025-03547
• Device Sequence Number: 10045525
• Product Code: FPA
• UDI-Device Identifier: 07613203021135
• UDI-Public: (01)07613203021135(17)280526(10)25055569
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 10010453
• Device Lot Number: 25055569
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown