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

Catalog Number	2426-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim it was reported by the customer that the tubing was then loaded into the iv pump and connected to the patient.The rn started the infusion and noticed that the iv tubing was back filling with the patient's blood.The iv infusion was paused, and the rn flushed the tubing with a 10cc ns flush through one of the iv ports on the tubing.When the rn flushed the tubing, he noticed that there was fluid leaking from the tubing.The rn then disconnected the tubing from the patient and inspected the tubing and located a defect where there was a hole in the tubing.
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
Material#: 2426-0500, batch#: 24013006.It was reported by the customer that the tubing was then loaded into the iv pump and connected to the patient.The rn started the infusion and noticed that the iv tubing was back filling with the patient's blood.The iv infusion was paused, and the rn flushed the tubing with a 10cc ns flush through one of the iv ports on the tubing.When the rn flushed the tubing, he noticed that there was fluid leaking from the tubing.The rn then disconnected the tubing from the patient and inspected the tubing and located a defect where there was a hole in the tubing.Verbatim: rcc received a complaint via email.Email(s) attached.The iv tubing was primed with the medication valproate, the tubing was then loaded into the iv pump and connected to the patient.The rn started the infusion and noticed that the iv tubing was back filling with the patient's blood.The iv infusion was paused, and the rn flushed the tubing with a 10cc ns flush through one of the iv ports on the tubing.When the rn flushed the tubing, he noticed that there was fluid leaking from the tubing.The rn then disconnected the tubing from the patient and inspected the tubing and located a defect where there was a hole in the tubing.Date of event: 12/10/2024, ref#: 2426-0500, lot#: (10)24013006.Additional info: 1.No harm, injury, or negative outcome to either patient or healthcare provider.2.There was 1 event so far.Tubing is available for return if needed.
Additional Manufacturer Narrative
The customer reported the tubing was leaking, and returned the used sample, of material 2426-0500, lot 24013006.Upon initial visual examination, the set had no defects or abnormalities.The test was infused with water to locate the issue, and the complaint was verified.There is a slice or cut in the tubing, about halfway between the pump segment and the male luer.The manufacturing site found the potential root cause for the tubing cut in middle of tubing to be related to material trapped in sealer machine.A quality alert was issued by the plant to communicate and reinforce the correct assembly procedure to personnel.Controls are in place along with sampling by technicians to continue to prevent these issues.A device history record review 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 PUMP MODULE SMARTSITE 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: 21032673
• Report Number: 9616066-2024-02152
• Device Sequence Number: 11792275
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: (01)07613203020992(11)240108(17)270108(10)24013006
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: 2426-0500
• Device Lot Number: 24013006
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 12/29/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown