MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP VSA SMBORE; INTRAVASCULAR ADMINISTRATION SET

Model Number	10010483
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
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 as lvp vsa smbore tubing leaked during use.The following information was provided by the initial reporter: "our nurses turned in a different tubing set that is leaking.".
Additional Manufacturer Narrative
H6: investigation summary the customer reported the tubing was leaking, and returned the used sample of model #10010483.The sample was clearly separated in the silicon tubing at the upper fitment, which verifies the complaint.The ring retainer remained attached with a short piece of silicon, and the rest of the tubing was ripped away.There is a known failure mode for improper loading of the pumping segment, we recommend loading the top blue clip into the pump first and then the bottom.A device history record review for model 10010483 lot number 20096231 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 10sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Several things could have caused the tear, and the root cause is unknown.
Event or Problem Description
It was reported that the as lvp vsa smbore tubing leaked during use.The following information was provided by the initial reporter: "our nurses turned in a different tubing set that is leaking.".

• Brand Name: AS LVP VSA SMBORE
• 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: 11898836
• Report Number: 9616066-2021-51173
• Device Sequence Number: 14380059
• Product Code: FPA
• UDI-Device Identifier: 50885403232600
• UDI-Public: 50885403232600
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K934095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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: 09/10/2023
• Device Model Number: 10010483
• Device Catalogue Number: 10010483
• Device Lot Number: 20096231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1