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

Catalog Number 2420-0007

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2023

Event Type  malfunction  

Event Description

It was reported that bd alaris pump module smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim.Iv tubing started leaking while infusing ivf.Blood baked up on the line and caused a clot.Iv had to be replaced.Defective tubing replaced.Srs completed.

Manufacturer Narrative

Initial reporter facility name- (b)(6)hospital of orange county children's specialists.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

The customer reported that the infusion set is defective and started leaking.No product or photo was returned by the customer.The customer complaint of tubing deffective/damaged could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 2420-0007 lot number 1023015682 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 30jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information was provided.Material#: 2420-0007, lot#: 1023015682.It was reported by the customer that the iv tubing started leaking while infusing ivf.Verbatim: rcc received a complaint via email.Email(s) attached.Iv tubing started leaking while infusing ivf.Blood baked up on the line and caused a clot.Iv had to be replaced.Defective tubing replaced.Srs completed.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
• Type of Device: 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: 18656054
• MDR Text Key: 334737451
• Report Number: 9616066-2024-00203
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

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
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: 1023015682
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1