MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1063KP

Device Problem Air/Gas in Device (4062)

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

Event Date 07/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was an air bubble approximately 5cm in length in the peripherally inserted central catheter (picc) line attached to a large volume infusor.This occurred during patient infusion.The device had been filled with cefepime 6000mg in sodium chloride 0.9%.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4, and h6.H4: the device was manufactured from february 24, 2021 - february 25, 2021.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.When the luer cap was removed, evidence of continuous flow of fluid was observed coming out of the line.A functional flow rate test was performed and found to be within the product specification range.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12275035
• MDR Text Key: 264984938
• Report Number: 1416980-2021-04783
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081366
• UDI-Public: (01)00085412081366
• Combination Product (y/n): Y
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

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: Lay User/Patient
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 21B044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 08/30/2021
• Supplement Dates FDA Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CEFEPIME 6000MG; PERIPHERALLY INSERTED CENTRAL CATHETER; SODIUM CHLORIDE 0.9%; CEFEPIME 6000MG; PERIPHERALLY INSERTED CENTRAL CATHETER; SODIUM CHLORIDE 0.9%