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

Catalog Number 955558

Device Problem Device Alarm System (1012)

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

Event Date 09/21/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter postal code: 8750.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy (crrt) with prismax machine equipped with a thermax blood warmer, two treatments (started on the night of the event and into the following day) were terminated due to the multiple alarms related to discharge scale followed by the ¿reboot¿ of the machine, and one treatment (on the third day) was terminated due to thermax lock being open during therapy.Extracorporeal blood was not returned to the patient (approximately 2 x 217ml ) and a blood transfusion was required.No additional information is available.

Manufacturer Narrative

Additional information added to h3, h6 and h10.The actual device was not provided; however, three (3) pictures were provided for evaluation.Visual inspection of pictures the showed the alarm screen for ¿effluent weight error¿ and the third picture showed treatment parameter configuration.The event history log review showed the first treatment was interrupted after multiple alarms dialysate weight error and replacement weight error.The system halted (alarm general system failure), rebooted, and restarted, but the user decided to end the treatment.Another treatment was started immediately after the first.An alarm for thermax disposable unlock appeared approximately 4 hours into the treatment.This alarm has different potential caused that the ones occurred during the first treatment.The second treatment was interrupted, and a third treatment was started on the afternoon of the same day.The prismax triggered alarms effluent weight error ¿multiple¿.The cause of these repeated alarms was an incorrect procedure of change of the effluent bag as the user changes the effluent bag without entering the process of bag change tapping onto the bag icon on the screen, neither opening the scale, but just removing and replacing the effluent bag.The reported multiple events were caused by mis-practices of the clinical staff not following the instructions of the operator¿s manual and of the on- screen labelling for the solution bags replacement.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The investigation didn¿t find any evidence of malfunction or defects of the prismax.The prismax operator's manual instructs the user about the correct procedure of solution bag replacement.In detail to change a bag the user is requested to tap the graphic icon of the bag to be replaced, and follow the onscreen instructions.The online menu instructs to open the scale completely and clamp the line when changing the bag.The display shows the opened scale with color and shape coding.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: 15633789
• MDR Text Key: 302025407
• Report Number: 3003504604-2022-00028
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412630359
• UDI-Public: (01)00085412630359
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: No
• 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: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female