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

Catalog Number 955626

Device Problem Device Alarm System (1012)

Patient Problem Blood Loss (2597)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that two hours into a continuous renal replacement therapy treatment with a prismax machine, a system failure, call service alarm and an access extremely negative alarm, were generated.The treatment was interrupted and the extracorporeal blood was not returned to the patient.Treatment was restarted with another prismax machine, resulting in additional blood loss and a blood transfusion.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).

Manufacturer Narrative

H9: 3003504604-04/21/21-001-c.H10: the device was inspected on site by a qualified baxter technician and the arps (automatic repositioning system segment) was replaced.A device history review revealed no issues that could have caused or contributed to the reported issue.The lox files were reviewed and the reported condition was verified.Should additional relevant information become available, a supplemental report will be submitted.H10: the device was inspected on site by a qualified baxter technician.A prime test and simulated self test were performed with no issues noted.A device history review revealed no issues that could have caused or contributed to the reported issue.The lox files did not identify any treatment for the reported event date.The cause of the condition could not be determined.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: 11142771
• MDR Text Key: 226008460
• Report Number: 1416980-2020-08412
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (y/n): Y
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/08/2021
• Supplement Dates Manufacturer Received: 03/18/2021; 05/21/2021
• Supplement Dates FDA Received: 03/23/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTO EFFLUENT SET; PRISMAFLEX SET; PRISMASOL SOLUTION; THERMAX POUCH
• Patient Outcome(s): Required Intervention