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 Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 10/09/2023

Event Type  malfunction  

Manufacturer Narrative

A2.Patient¿s birthday was not provided, 01-jan-xxxx was used based on age of patient.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event 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: at 0610, rn called into room by mom due to leaking iv tubing.On observation, iv tubing had a hole where kinked.Blood had been backed up into tube and began leaking in patient's bed.Pt's sip line was clamped and iv tubing was then disconnected.Date of occurrence (b)(6) 2023.

Event Description

No additional information was provided.Materials#: 2420-0007; batch#: 23065469.It was reported by the customer that rn called into room by mom due to leaking iv tubing.On observation, iv tubing had a hole where kinked.Verbatim: rcc received a complaint via email.Email(s) attached.At 0610, rn called into room by mom due to leaking iv tubing.On observation, iv tubing had a hole where kinked.Blood had been backed up into tube and began leaking in patient's bed.Pt's sip line was clamped and iv tubing was then disconnected.Date of occurrence: (b)(6) 2023.Patient initials/mrn: aga.Age: 4 years.Sex: male.What they are being treated for: all.Product brand name bd alaris pump infusion set; product ref # (b)(4); product lot # (23065469).

Manufacturer Narrative

It was reported by the customer that the iv tubing was leaking.One sample was received for quality investigation.Visual inspection was conducted on the infusion set and a hole was identified in the tubing.The infusion set was then primed to confirm that the tubing was leaking.Leakage was verified coming from the hole in the tubing.The investigation was forwarded to the manufacturing location to determine if further information could be conducted.After determining that failure reported was found during the infusion, manufacturing could not confirm the possible root causes for the failure.A root cause for the failure could not be determined.A device history record review for model 2420-0007 lot number 23065469 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 27jun2023.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.

• 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: 18298544
• MDR Text Key: 330833748
• Report Number: 9616066-2023-02358
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2023
• 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: 23065469
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male