MAUDE Adverse Event Report: AS LVP 20D 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0007

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the as lvp 20d 3ss cv experienced air in line.The following information was provided by the initial reporter: the previous infusion was beeping but had some medication left in the bottle so the old bottle was removed and the new bottle was spiked.She completed her scanning (scanned patient, bottle and pump), checked the rate (green screen) and started the new infusion.She did report that she saw drips falling in the tubing drip chamber the pump module was not opened and the iv set was not changed.She returned to the patients room 30-40 minutes later to transport the patient and found pump module alarming for air-in-line.The bottle was empty and she observed air in the tubing.At that point she noticed the patient was slumped and a rapid response was called.She paused the pump module and checked for leaks of the iv set and the line was still ¿good.¿ the nurse was instructed to monitor the patient¿s heart rate and blood pressure and fluids were administered.The patient needed minimal intervention and no patient harm.Iv set was misloaded in the pump module.Medication was a glass bottle of precedex 400mcg/m.Iv set vent was in closed position.No obvious signs of fluid in the pumping segment.Start date and time sticker on precedex iv set 5/23 1400.

Manufacturer Narrative

H.6.Investigation: six photos were returned by the customer.It was reported that the tubing has air in line.The photos show the tubing and set-up, however, they do not verify the complaint.A device history record review could not be performed on model 2426-0007 because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.

Event Description

It was reported that the as lvp 20d 3ss cv experienced air in line.The following information was provided by the initial reporter: ¿ the previous infusion was beeping but had some medication left in the bottle so the old bottle was removed and the new bottle was spiked ¿ she completed her scanning (scanned patient, bottle and pump), checked the rate (green screen) and started the new infusion o she did report that she saw drips falling in the tubing drip chamber o the pump module was not opened and the iv set was not changed ¿ she returned to the patient's room 30-40 minutes later to transport the patient and found pump module alarming for air-in-line o the bottle was empty and she observed air in the tubing ¿ at that point she noticed the patient was slumped and a rapid response was called o she paused the pump module and checked for leaks of the iv set and the line was still ¿good¿ o the nurse was instructed to monitor the patient¿s heart rate and blood pressure and fluids were administered ¿ the patient needed minimal intervention and no patient harm ¿ iv set was misloaded in the pump module.¿ medication was a glass bottle of precedex 400mcg/m.¿ iv set vent was in closed position.¿ no obvious signs of fluid in the pumping segment.¿ start date and time sticker on precedex iv set 5/23 1400.

• Brand Name: AS LVP 20D 3SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12453011
• MDR Text Key: 270917368
• Report Number: 9616066-2021-52001
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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