MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number	24600-0007
Medical Device Problem Codes	Leak/Splash (1354); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: the customer reported the tubing has connection issues with the icu medical product, and returned a picture of the sample.The picture does not verify the failure, only the setup of the icu and bd products.A device history record review could not be performed on model #24600-0007 because a lot number was not provided by the customer.The root cause for the connection issues and leakage cannot be determined without a sample investigation.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
It was reported that the as lvp 20d low sorb 3ss cv tubing separated from the icu medical spiros during use.Additionally, it was reported that the clamp on the tubing moved too easily and caused fluid reflux.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "nurses provided feedback regarding tubing not working really well when connected to bd alaris tubing; noting tubing does not appear to be user friendly, stopcock on tubing being sensitive with occasional fluid reflux back into carrier fluid tubing noted".
Event or Problem Description
It was reported that the as lvp 20d low sorb 3ss cv tubing separated from the icu medical spiros during use.Additionally, it was reported that the clamp on the tubing moved too easily and caused fluid reflux.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter: "nurses provided feedback regarding tubing not working really well when connected to bd alaris tubing; noting tubing does not appear to be user friendly, stopcock on tubing being sensitive with occasional fluid reflux back into carrier fluid tubing noted".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 20105683 d.4.Medical device expiration date: 10/8/2023 h.4.Device manufacture date: 10/8/2020 d.4.Medical device lot #: 21015588 d.4.Medical device expiration date: 1/9/2024 h.4.Device manufacture date: 1/9/2021 d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 6/21/2021 h.6.Investigation: the customer reported the tubing has connection issues with the icu medical product, and returned a picture of the sample, along with 5 unused sample and 3 unused icu medical needleless connectors.The picture does not verify the failure, only the setup of the icu and bd products.The samples were tested by priming with blue dye fluid with both the icu medical product and the stopcock (all relevant connections).There were no observed leaks with any of these connections, and the complaint cannot be verified.A device history record review for model 24600-0007 lot number 20105683 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the connection issues and leakage cannot be determined without an observed failure.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of connection issues and leakage with lot #20105683 regarding item #24600-0007.

• Brand Name: AS LVP 20D LOW SORB 3SS 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
• MDR Report Key: 12013324
• Report Number: 9616066-2021-51326
• Device Sequence Number: 11838792
• Product Code: FPA
• UDI-Device Identifier: 50885403241978
• UDI-Public: 50885403241978
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/27/2021

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 Model Number: 24600-0007
• Device Catalogue Number: 24600-0007
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 07/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1