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

Catalog Number 955558

Device Problem Filling Problem (1233)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient was receiving continuous renal replacement therapy using a prismax machine.While troubleshooting alarms, it was noticed the heparin syringe, reported as ¿nearly full¿ became empty, indicating excessive heparin delivery.It was further reported that a clotting sample and anti xa assay sample were sent before and after the protamine sulfate was administered, and the patient observed for sign of bleeding.There was no report of patient injury associated with this event.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation; however, the machine was evaluated on-site by a baxter technician.External inspection was performed, and no issues were noted.No machine malfunction was identified during technical evaluation.The review of the log files revealed that the clotting of the filter and continuous attempts to resume the treatment caused the pressures in the extracorporeal circuit to deviate dramatically from the expected conditions.The filter pressure dropped down dramatically in the negative range.The machine alarmed t1298 ¿syringe force low¿ at 16:11:29 as a result of the negative filter pressure.As a result of the same pressure condition, the anticoagulant fluid content of the syringe was sucked into the extracorporeal circuit.This was because, contrary to the instruction for use (ifu), the user didn¿t secure the syringe piston with the provided lock.The operator manual instructs the user to ¿clamp the syringe line when changing the syringe.When the syringe is installed, follow the onscreen instructions to connect the syringe correctly, closing the plunger clip and to unclamp the syringe line¿.The most likely cause of the reported event was associated with use error.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported 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; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18651719
• MDR Text Key: 334675321
• Report Number: 3003504604-2024-00001
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

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?: No
• 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: 01/10/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/28/2024
• 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
• Patient Outcome(s): Required Intervention