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

Catalog Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 06/14/2022

Event Type  malfunction  

Event Description

It was reported that 1 bd alaris¿ lvp 20d 2ss cv had check valve malfunction issues.The following information was provided by the initial reporter : the customer reported that the primary bag mounted on the pole and lowered the secondary bag down below the primary (the entire infusion kit set clamped downstream of the junction between the two kits) to re-fill the secondary.Then raised the secondary bag back above the primary bag (mounted correctly on the pole with an 8â¿쳌 head), we observed rapid backflow from the secondary kit into the primary.This test was repeated multiple times to the same result.This clearly shows that the bcv was malfunctioning and was the root cause of this incident.In the process of this testing, the bcv began to function correctly and is currently preventing backflow.Event date: (b)(6) 2022.

Manufacturer Narrative

Initial reporter second 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 1 bd alaris¿ lvp 20d 2ss cv had check valve malfunction issues.The following information was provided by the initial reporter : the customer reported that the primary bag mounted on the pole and lowered the secondary bag down below the primary (the entire infusion kit set clamped downstream of the junction between the two kits) to re-fill the secondary.Then raised the secondary bag back above the primary bag (mounted correctly on the pole with an 8â¿쳌 head), we observed rapid backflow from the secondary kit into the primary.This test was repeated multiple times to the same result.This clearly shows that the bcv was malfunctioning and was the root cause of this incident.In the process of this testing, the bcv began to function correctly and is currently preventing backflow.Event date: june 14, 2022.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 01-jul-2022.H6: investigation summary one sample was received for quality investigation.The customer complaint of check valve failure was not verified by investigation.Evaluation was conducted by simulating an infusion using the sample provided.The primary infusion set was primed with saline solution and the secondary set, that was supplied with the sample, was primed using a solution with blue dye to determine if the check valve is allowing for backflow into the primary infusion bag.The primary infusion set was set to pump at a rate of 200ml/hr.The secondary infusion bag, with dyed water, was placed 9 inches above the primary infusion bag and the infusion was monitored to see if the dyed liquid would travel back past the check valve into the primary infusion bag.There was no backflow past the check valve observed.The secondary infusion bag height in comparison to the primary bag height was adjusted to try and simulate the reported failure.There were no instances, at different height levels, where they dyed liquid traveled backwards past the primary infusion set check valve.No other issues were noted during the investigation.A device history record review for model 2420-0007 lot number 22036099 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 17mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not be established because the reported failure could not be replicated.

• Brand Name: BD ALARIS¿ 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15032627
• MDR Text Key: 304540250
• Report Number: 9616066-2022-00889
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• Combination Product (y/n): Y
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2420-0007
• Device Lot Number: 22036099
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/17/2022
• 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