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

Catalog Number 955558

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Blood Loss (2597)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6). The control unit was not received for evaluation. The event history log review identified that the cause of the event was due to use error when programming the treatment prescription. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Use errors and proper instructions are address on the display of the prismax monitor during setup. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

This is a case report received on the (b)(6) 2020 by baxter (b)(6) from the health facility (b)(6). Reportedly, during adjustment of flow ratios at prismax machine the pre-blood pump (pbp) and patient fluid removal rate (pfr) were confused. This caused that the settings which were set for pbp, were set for patient withdrawal. No symptoms. No further patient or treatment related data was provided. Additional information received on the 19th of january 2021: the patient was given an additional 2 erythrocyte concentrates and the fluid withdrawal at the prismax was temporarily discontinued. The patient stabilized very quickly.

• Brand Name: PRISMAX
• 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 60073 ; 2242702068
• MDR Report Key: 11261141
• MDR Text Key: 229812180
• Report Number: 1416980-2021-00292
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: FA-2020-064

Patient Treatment Data

Date Received: 02/01/2021 Patient Sequence Number: 1