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	24600-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 had flow issues during the docetaxel infusion.The following information was provided by the initial reporter: "docetaxel bag with attached secondary line connected to primary non-dehp line.Secondary line back-flushed to clear air.Once secondary bag (docetaxel) hung higher to primary bag writer noticed that docetaxel fluid was free-flowing back into primary bag.Primary bag chamber filled and possibly filled into the primary bag.Unknown amount of chemo drug lost to primary bag.Writer noted that the non-dehp line did not have a back check valve.Entire line disconnected from patient.New non-dehp line primed and attached to patient.Docetaxel remixed by pharmacy and infusion commenced without further issue.".
Additional Manufacturer Narrative
Investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The primary set was primed with normal saline and clamped above the first smartsite.The secondary set was primed with blue dye water and attached to the first smartsite.The secondary set was allowed to free flow.No back flow was observed.The customer complaint that the fluid from the secondary bag was free-flowing back into the primary bag could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 24600-0007 lot number 21055152 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ low sorbing infusion set had flow issues during the docetaxel infusion.The following information was provided by the initial reporter: "docetaxel bag with attached secondary line connected to primary non-dehp line.Secondary line back-flushed to clear air.Once secondary bag (docetaxel) hung higher to primary bag writer noticed that docetaxel fluid was free-flowing back into primary bag.Primary bag chamber filled and possibly filled into the primary bag.Unknown amount of chemo drug lost to primary bag.Writer noted that the non-dehp line did not have a back check valve.Entire line disconnected from patient.New non-dehp line primed and attached to patient.Docetaxel remixed by pharmacy and infusion commenced without further issue.".

• 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: 12800981
• Report Number: 9616066-2021-52415
• Device Sequence Number: 11956600
• Product Code: FPA
• UDI-Device Identifier: 50885403241978
• UDI-Public: 50885403241978
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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 Expiration Date: 05/06/2024
• Device Model Number: 24600-0007
• Device Catalogue Number: 24600-0007
• Device Lot Number: 21055152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Supplement Date Received by Manufacturer: 01/18/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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