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

Catalog Number 955558

Device Problems Use of Incorrect Control/Treatment Settings (1126); Improper or Incorrect Procedure or Method (2017)

Patient Problem Hypovolemia (2243)

Event Date 04/13/2021

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that at an unknown time during continuous renal replacement therapy using a prismax machine, the nurse mistakenly entered the pre blood pump flow rate into patient fluid removal and removed 1200 ml of fluid from the patient.The patient became hypovolemic and required a bolus of plasmalyte 500mls and 750mls albumin to compensate for the excessive fluid removal.The patient did not suffer any other adverse event.No additional information is available.

Manufacturer Narrative

Additional information: corrected information added to h6- device code.Code a2303 was added to capture user error.H10: a device history review revealed no issues that could have caused or contributed to the reported issue.The device was not returned; therefore, a device analysis could not be completed, however, based on the reported event description, the reported condition was verified.The cause was design related.This issue is being further investigated.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11790823
• MDR Text Key: 249479515
• Report Number: 1416980-2021-02730
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• 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: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR