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

Model Number	2465-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.Unknown, (b)(6), 00000 usa has been used as a default.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ low sorbing infusion set adapter separated from the tubing and caused chemo to leak out.The following information was provided by the initial reporter: "i had a chemo rn call down this evening to notify me that the closed system adapter that connects the tubing to the bag has been popping off, thus causing chemo leaks.I know this happened with a patient last week where 2/3 of the bag leaked and the next day we re-made this chemo.Today it was caught soon enough where no re-making was necessary.".
Additional Manufacturer Narrative
H6: investigation summary the customer reported the filter had traces of residue, and returned one used sample of material 2465-0007.The sample was primed with blue dye water and the filter was found to leak from both air vent membranes.The membranes were observed to be blue which is a clear sign they were wetted out.This is a known issue with chemo drugs, that typically have high alcohol percentage that can 'wet out' the filter.These types of drugs need changing more often with filters, we usually recommend a maximum of 12 hour drip time, reach out to customer advocacy for more information.No other failure modes observed.A device history record review for model 2465-0007 lot number 21016529 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27jan2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ low sorbing infusion set adapter separated from the tubing and caused chemo to leak out.The following information was provided by the initial reporter: "i had a chemo rn call down this evening to notify me that the closed system adapter that connects the tubing to the bag has been popping off, thus causing chemo leaks.I know this happened with a patient last week where ~2/3 of the bag leaked and the next day we re-made this chemo.Today it was caught soon enough where no re-making was necessary.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12715776
• Report Number: 9616066-2021-52328
• Device Sequence Number: 19955460
• Product Code: FPA
• UDI-Device Identifier: 50885403221949
• UDI-Public: 50885403221949
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: Health Professional
• Device Expiration Date: 01/27/2024
• Device Model Number: 2465-0007
• Device Catalogue Number: 2465-0007
• Device Lot Number: 21016529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown