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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismax machine, a prismaflex st150 set and a thermax blood warmer unit, alarms for "thermax cover open" and "return extremely positive'" were generated.Treatment was stopped without extracorporeal blood (ec) returned to the patient.A blood loss of 217 ml was reported.The patient received a blood transfusion.After the patient was disconnected, blood was visible in the effluent bag.No additional information is available.

Manufacturer Narrative

Additional information added to b1, h1, h3, h6 and h10.The device was not received for evaluation; however, it was inspected on-site by a baxter qualified technician.The device was lined and primed with no issues noted.A short 20-minute simulated therapy was successfully performed.No malfunction was detected.An event history log review was performed, and no clear device malfunction was identified as the prismax machine was triggering dedicated alarms to notify the user of the conditions with the machine or setup.The log file confirmed that no bld alarms are recorded, and the blood observed passing to auto effluent occurred after the patient was disconnected from the treatment.A device history review revealed no issues that could have caused or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Based on additional information received, the prismax machine was determined not to be a factor in the reported adverse event.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; brooklyn park MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16102445
• MDR Text Key: 306701105
• Report Number: 3003504604-2022-00044
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

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: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 01/05/2023
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 02/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PRISMAFLEX ST150 SET; THERMAX BLOOD WARMER UNIT
• Patient Outcome(s): Required Intervention