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

Catalog Number	24600-0007
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
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
It was reported that bd alaris pump module smartsite low sorbing infusion set was damaged the following information was received by the initial reporter with the following verbatim: we had an incident today at lmh involving a chemotherapy spill.It is suspected that it occurred as a result of a faulty iv set (ref24600-0007).We have kept the set so that we can send it back for investigation; however, it still has an empty bag of chemotherapy attached to it.
Additional Manufacturer Narrative
The customer reported that there was a chemotherapy spill due to a faulty iv set.One sample of material number 24600-0007 was received for quality evaluation.Visual inspection of the infusion set was conducted and no clear damages or abnormalities were identified.The infusion set was then primed and leakage was identified in the tubing above the check valve.The customer complaint of component damage - leak was verified.The investigation was forwarded to the manufacturing facility for further evaluation.After the investigation along with manufacturing and quality operations team, the most possible root because that generates a component damage - leak is an excess of solvent due an intermittent function of the solvent dispenser or due an incorrect application of solvent by the production personnel.An update in the to the maintenance procedure for the dispenser along with a quality alert to reinforce the correct usage of the solvent dispensers and expander fixtures were implemented to correct the issue.A device history record review for model 24600-0007 lot number 23035207 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 14mar2023.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 or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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: 19945098
• Report Number: 9616066-2024-01112
• Device Sequence Number: 15472486
• Product Code: FPA
• UDI-Device Identifier: 10885403241970
• UDI-Public: (01)10885403241970
• 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): 11/20/2024

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
• Operator of Device: Other
• Device Catalogue Number: 24600-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/26/2024
• 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