MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAX TUBING; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number M150

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  malfunction  

Event Description

Within 3 minutes of initiating crrt (continuous renal replacement therapy) on a patient the tubing was saturated with air, leaving a large amount of air bubbles in the line.This set was unusable, and the blood could not be returned to the patient.The rn secured another crrt prismax machine and hung another set from the same supply room.Within 2 minutes of initiating the therapy, this set was also filled with diffuse air and the blood could not be returned to the patient.Upon getting another set from a different batch off unit, the therapy was able to be initiated without difficulty.Manufacturer response for crrt tubing, (brand not provided) (per site reporter): notified baxter.[redacted date]: baxter complaint # (b)(4); responded to baxter questionnaire.[redacted date]: rma received.[redacted date]: sample shipped ups.

• Brand Name: PRISMAX TUBING
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 14309028
• MDR Text Key: 290937255
• Report Number: 14309028
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M150
• Device Catalogue Number: 109990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other