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

Catalog Number 10013364T

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

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

E4.The initial reporter also notified the fda on 25 oct, 2023.Medwatch report # mw5147804 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 smartsite texium secondary set was damaged and leaked.The following information was received by the initial reporter with the following verbatim: patient due for carboplatin infusion.Nurse picked up carboplatin on secondary tubing from chemotherapy bag and went to get a second nurse check when realized chemotherapy was leaking onto nurse's body.Upon inspection of secondary tubing, the tubing directly below the drip chamber was severed/broken off.Pharmacy was notified and spill kit obtained while nurse exposed showered.Rn (registered nurse) followed up with employee health.

Event Description

New info from customer lot#2305917.

Manufacturer Narrative

The customer reported secondary tubing broke apart at the drip chamber, and returned photos of material 10013364t and lot 23029136.The pictures of the set were examined, and the complaint of separation at the drip chamber was verified.The root cause of the failure was related to the solvent application process to the tubing.A trend for the drip chamber separation issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project to examine how to further increase the robustness of the disposable device and prevent future occurrences of this type.As part of the action plan, the solvent dispenser process was updated.Customer complaint trends will also continue to be evaluated on a monthly basis.We value the satisfaction of our customers and thoughtfully consider all reported complaints.It is our top priority to maintain your confidence in our products.We thank you for your support.Device history record review for model 10013364t lot number 23029136 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16mar2023.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 SMARTSITE TEXIUM SECONDARY 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 NJ 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18502414
• MDR Text Key: 333502838
• Report Number: 9616066-2023-02515
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

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: 10013364T
• Device Lot Number: 23029136
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/14/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White