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

Catalog Number 955558

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Type  malfunction  

Manufacturer Narrative

The event occurred on an unreported date in 2022.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy on a prismax machine, the operator accidentally programmed the patient fluid removal rate (pfr) as the flow rate prescribed for the pre blood pump (pbp).This led to an excessive fluid removal of 3217 ml.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction: h7 and h9.H9: 3003504604-03/07/22-001-c and 9616240 03/07/22-001-c additional information: h6 and h10.The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.A device history review revealed no issues that could have caused or contributed to the reported issue.The prismax graphic user interface (gui) includes set up mode for entering the prescription setup.To enter the patient fluid removal (pfr) setting, the operator¿s manual instructs the user to enter the set-up mode menu, to go to prescription step and then tap the ¿other settings¿ button to view or change settings, including cit/cal anticoagulation reminder, return pressure drop limit (default 70 mmhg), gain/loss limit or pfr catch-up availability.The pfr rate can be set in to 0 ml/h (default value or in the range 10¿2000 ml/h maximum; the actual range is specific to the therapy or to the disposable set in use).Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14002247
• MDR Text Key: 298294432
• Report Number: 3003504604-2022-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

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: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 05/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1