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 22603-B007T

Device Problem Leak/Splash (1354)

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

Event Date 02/27/2024

Event Type  malfunction  

Event 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 following verbatim: verbatim: chemo leaking from bag access port.Xxxxx- there have been 2 occurrences in the past 2 weeks: (b)(6) 2024 a few drops of fluid noticed by the nurse inside the inner chemo bag after it was hand-delivered to the oncology clinic.Upon inspection, leak was determined to be coming from the bag access port.Medication was perjeta which was prepared in pharmacy using a bbraun 250 ml excel bag and spiked with the bd alaris pump infusion set shown below.The tubing was primed by pharmacy and no issues were noted during preparation or delivery.A new dose was prepared using the same lot number of tubing and delivered to the unit without issue.(b)(6) 2024 the bag access port was noted to be damp when the nurse was infusing a bag of cisplatin.The cisplatin was prepared in pharmacy using a bbraun 500 ml excel bag which was spiked with the bd alaris pump infusion set below and primed.No issues were noted by pharmacy during preparation or hand-delivery of the medication.The infusion was completed without any significant loss of drug from the tubing, just moisture noted on the bag access port.The bag access port was not used by pharmacy or nursing in either case of the cases listed above.We are obviously very concerned about the leaking of hazardous medications from these tubing sets.We have started attaching a closed system luer lock adaptor to the bag access port to prevent this from occurring in the future.We do not believe this should be necessary but appears to be based on our recent experience.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE TEXIUM LOW SORBING 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: 19033020
• MDR Text Key: 339252444
• Report Number: 9616066-2024-00518
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403240942
• UDI-Public: (01)10885403240942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 22603-B007T
• Device Lot Number: 23075056
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• 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