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

Catalog Number	2420-0500
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion set tubing would not clamp the following information was received by the initial reporter with the following verbatim type of incident/problem: malfunction - during or after use level of harm: no apparent harm - reached patient/person ahs optional report to cmdsnet (health canada): yes incident details: line removed from channel, safety blue lock did not clamp infusion still running and patient received free flowing levophed.Who was affected? patient frequency of problem: first time.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
It was reported by customer that line removed from channel, safety blue lock did not clamp infusion still running and patient received free flowing.One sample received for evaluation.There were no visual damages or abnormalities.The tubing was primed and a simulated infusion conducted at 125ml/hr for 1 hour with bd calibrated alaris pump.The door of the pump was opened, and the set was inspected to see if the clamp was closed.This test was conducted 10 times.The slide clamp at the lower pumping segment fitting operated as intended each time.Failure was not replicated.A root cause was not determined because the failure was not replicated.A device history record review could not be performed because the lot number is unknown.
Event or Problem Description
Material # 2420-0500 , batch # unknown.It was reported by customer that line removed from channel, safety blue lock did not clamp infusion still running and patient received free flowing levophed.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2024.Type of incident/problem: malfunction - during or after use.Level of harm: no apparent harm - reached patient/person.Ahs optional report to cmdsnet (health canada): yes.Incident details: line removed from channel, safety blue lock did not clamp infusion still running and patient received free flowing levophed.Who was affected? patient.Frequency of problem: first time.Device information: device name/description: set alaris pump primary 20 drop 2y with check valve smartsite 116 inch pv 18ml.Manufacturer: carefusion.Manufacturer code/model: 2420-0500.Serial or lot number: unknown.Expiry date: unknown.Supplier:(b)(4).Supplier catalogue number: al2420-0500.Is device retained: yes.Number of devices: 1.Device handling hazards (when blank = hazards not specified): other wipe, contained, labeled? wiped, double-bagged, labelled.

• 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: 20759025
• Report Number: 9616066-2024-01722
• Device Sequence Number: 9356224
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: (01)07613203012430
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

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: 2420-0500
• 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: 10/25/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/22/2025
• 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