MAUDE Adverse Event Report: AS LVP 20D 1.2M; INTRAVASCULAR ADMINISTRATION SET

Model Number 2202-0007

Device Problem Air/Gas in Device (4062)

Patient Problem Air Embolism (1697)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that as lvp 20d 1.2m had air in the line.The following information was provided by the initial reporter: it was reported by the customer that there are having issues with air pulling into the 1.2 micron filter tubing.Verbatim: patient was a (b)(6) gestational age infant with a cardiac defect.The patient had an atrial line in place.The infusion was lipids at 1.6mls per hour.The packaging was discarded so no lot number available.There was an unknown stopcock in between the catheter and the end of the line.The infusion was being delivered on the large volume pump.The devices were not sequestered.Unsure of serial numbers.There was air noted in the filter and below the filter.They believe the air traveled into the patient from the filter."we are having an issue with air pulling into the 1.2 micron filter tubing.Specifically, the air was pulling in from the filter." "on scan the patient was noted to have air bubbles in the right atrium and they suspect air traveled to the gut causing the infant to become very sick.".

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.The customer complaint that there are having issues with air pulling into the 1.2 micron filter tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2202-0007 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that as lvp 20d 1.2m had air in the line.The following information was provided by the initial reporter: it was reported by the customer that there are having issues with air pulling into the 1.2 micron filter tubing.Verbatim: patient was a 37 week gestational age infant with a cardiac defect.The patient had an atrial line in place.The infusion was lipids at 1.6mls per hour.The packaging was discarded so no lot number available.There was an unknown stopcock in between the catheter and the end of the line.The infusion was being delivered on the large volume pump.The devices were not sequestered.Unsure of serial numbers.There was air noted in the filter and below the filter.They believe the air traveled into the patient from the filter."we are having an issue with air pulling into the 1.2 micron filter tubing.Specifically, the air was pulling in from the filter." "on scan the patient was noted to have air bubbles in the right atrium and they suspect air traveled to the gut causing the infant to become very sick.".

• Brand Name: AS LVP 20D 1.2M
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12392405
• MDR Text Key: 268968655
• Report Number: 9616066-2021-51930
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403274037
• UDI-Public: 50885403274037
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2202-0007
• Device Catalogue Number: 2202-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 9 MO