MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number ASKU

Device Problem Air/Gas in Device (4062)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified pump presented an air in line alarm during use with two (2) secondary medication sets.It was stated that when the secondary infusions were complete, the pump was programmed to go to the primary set to continue a saline infusion.The pump then alarmed air in line.It was stated the infusion either started pulling air from the medication bag which was completely empty or when it began to infuse the primary line where the primary line may have been unable to infuse and air in line was the result.It was reported that both lines were properly primed and the primary line was on the hanger below the piggyback.This occurred during a vancomycin infusion and also during a remdesivir infusion.There was no patient injury or medical intervention associated with these events.No additional information is available.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12467557
• MDR Text Key: 271267623
• Report Number: 1416980-2021-05681
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• 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
• Treatment: PUMP; REMDESIVIR; SALINE; VANCOMYCIN