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

Model Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Initial reporter phone #: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the as lvp 20d 2ss cv experienced overinfusion.The following information was provided by the initial reporter: we believe we had an overinfusion event at lh on monday.Our biomed team has done a review of the pump and has found the accuracy to be acceptable.I know there have been reports of overinfusion events at times since we began using these pumps.

Event Description

It was reported that the as lvp 20d 2ss cv experienced overinfusion.The following information was provided by the initial reporter: we believe we had an overinfusion event at lh on monday.Our biomed team has done a review of the pump and has found the accuracy to be acceptable.I know there have been reports of overinfusion events at times since we began using these pumps.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for evaluation: yes.D10: returned to manufacturer on: 2021-10-12.H6: investigation summary: one sample (model #2420-0007) was returned by the customer and investigated under (b)(4).No anomalies were observed during the inspection of the returned set.The set passed rate accuracy testing with no unregulated flow observed during the testing process.The failure was unable to be replicated, and the complaint could not be verified.A device history record review for model 2420-0007 lot number 21066171 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause was unable to be determined because the failure was unable to be replicated.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: AS LVP 20D 2SS CV
• Type of Device: 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: 12513549
• MDR Text Key: 272732983
• Report Number: 9616066-2021-52110
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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
• Device Operator: Other
• Device Expiration Date: 06/22/2024
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 21066171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1