MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D LOW SORB 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013072
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris¿ lvp 20d low sorb 2ss cv there were flow issues.There was no report of patient impact.The following information was provided by the initial reporter: writer back primed medication and noticed medication continued to flow through secondary line.Line was set into pump and lower claps closed.Writer followed the line to find the medication was draining into saline chamber even though saline was hung low.Writer clamped medication.Notified charge nurse and pharmacist.Writer also notified unit nursing attendant.Writer showed pharmacist issue, and pharmacy deemed best to make new medication and waste chemo bag.Writer disposed of line and medication and hung new line.Writer hung new line and attached to nacl the second line also broke just below the chamber hub.No medication attached.Writer brought this line to nursing attendant.Third line was fine.Date of incident (yyyy-mm-dd): (b)(6) 2023.Incident details: patient had docetaxel infusion ordered requiring a non-pvc line.Writer hung medication with attached secondary line to non--pvc attached to nacl.Writer back primed medication and noticed medication continued to flow through secondary line.Line was set into pump and lower claps closed.Writer followed the line to find the medication was draining into saline chamber even though saline was hung low.Writer clamped medication.Notified charge nurse and pharmacist.Writer also notified unit nursing attendant.Writer showed pharmacist issue, and pharmacy deemed best to make new medication and waste chemo bag.Writer disposed of line and medication and hung new line.Writer hung new line and attached to nacl the second line also broke just below the chamber hub.No medication attached.Writer brought this line to nursing attendant.Third line was fine.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
No product or photo was returned by the customer.It was reported by customer that medication was draining into saline chamber even though saline was hung low.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 10013072 lot number 22115368 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23nov2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB 2SS CV
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17475409
• Report Number: 9616066-2023-01658
• Device Sequence Number: 7341774
• Product Code: FPA
• UDI-Device Identifier: 37613203021228
• UDI-Public: (01)37613203021228
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2023

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: 11/17/2025
• Device Catalogue Number: 10013072
• Device Lot Number: 22115368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/07/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2022
• 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