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

Model Number 11522558

Device Problems Partial Blockage (1065); Free or Unrestricted Flow (2945)

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

Event Date 05/20/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 3ss cv bv allowed air to pass the ball valve during use.Additionally, a separate set failed to prime past the drip chamber due to flow issues.The following information was provided by the initial reporter: "they reported a recent event but there wasn't any details except that it allowed air to pass the ball valve, though they assured me they would get the information.This morning i took a look at this set that they handed me and ran fluids through it and was able to reproduce the event." "they also had a recent instance of failure to prime past the drip chamber, but the nurse threw it away and didn't report it.".

Manufacturer Narrative

Investigation summary: one sample (model 11522558), three photos, and one video were returned by the customer.It was reported by the customer that it allowed air to pass through the ball valve and failure to prime past the drip chamber.The returned video verifies the complaint.The returned sample was examined for defects and abnormalities.No defects or abnormalities were observed.The set was able to be primed with saline.A fair amount of air bubbles were observed during priming, but those were able to be removed.The set was infused with the bd alaris pump (dchu-0010) and pump module (dchu-0013) at 125 ml/hr with a vtbi of 125 ml.Fluid was found to be flowing normally.The infusion was completed without any issues.The failure was unable to be replicated.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model 11522558 lot number 20116056 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 Description

It was reported that the as lvp 20d 3ss cv bv allowed air to pass the ball valve during use.Additionally, a separate set failed to prime past the drip chamber due to flow issues.The following information was provided by the initial reporter: "they reported a recent event but there wasn¿t any details except that it allowed air to pass the ball valve, though they assured me they would get the information.This morning i took a look at this set that they handed me and ran fluids through it and was able to reproduce the event." "they also had a recent instance of failure to prime past the drip chamber, but the nurse threw it away and didn¿t report it.".

• Brand Name: AS LVP 20D 3SS CV BV
• 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
• MDR Report Key: 12020828
• MDR Text Key: 257511088
• Report Number: 9616066-2021-51339
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: 50885403232303
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/30/2021

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: Health Professional
• Device Expiration Date: 11/19/2023
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: 20116056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 06/30/2021
• Supplement Dates FDA Received: 07/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1