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

Catalog Number	24601-B007T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
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 texium low sorbing infusion set was leaking.The following information was received by the initial reporter with the verbatim we have experienced another incident of precipitation in the low sorbing texium tubing(24601-b007t) as well as the 0.2 micron filter with texium(20350et) during a 24 hour paclitaxel infusion.I do not have the lots available to me, but attached are photos of this.
Additional Manufacturer Narrative
Photo investigation: the customer reported the tubing precipitated and returned photos of the incident, of material 24601-b007t and unknown lot.The photo was visually examined and the issue of leakage/air in the line was verified by the photos.It appears to be an issue with the lower fitment of the pump segment, it is unclear whether it is the plastic tubing or silicon tubing to lower fitment attachment.A device history record review could not be performed on material 24601-b007t because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation on a physical sample.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 TEXIUM 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: 18423405
• Report Number: 9616066-2023-02447
• Device Sequence Number: 8109198
• Product Code: FPA
• UDI-Device Identifier: 50885403240957
• UDI-Public: (01)50885403240957
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 24601-B007T
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/01/2024
• Supplement Report FDA Received Date: 02/23/2024
• 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