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

Catalog Number 955558

Device Problem Protective Measures Problem (3015)

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

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported during continuous renal replacement therapy (crrt) with a prismax control unit and a prismaflex set, a patient experienced several clotting incidents over the span of five days despite using different types of anticoagulants.Extracorporeal blood was not returned to the patient.Blood loss was approximately 800 ml.No patient symptom was reported, however, the patient received blood two blood transfusions on the sixth day and one blood transfusion two days later.Negative access alarms were generated around 20-30 times in 24 hours.No additional information is available.

Manufacturer Narrative

H10: the device was not received for evaluation.A device history review revealed no issues that could have caused or contributed to the reported issue.The log file records reviewed only one of the treatment lasting 15 hours.An alarm t1298 syringe_force_low was triggered as a negative pressure of the return access and was transmitted to the filter pressure.This caused an uncontrolled suction of the anticoagulant fluid in the extracorporeal circuit.The cause of the heparin bolus was the user didn¿t lock the heparin syringe piston as required by the prismax operator¿s manual.The analysis of the log file did not reveal any anomaly of the pressure measurement during and after the repositioning of the pod.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: 14396186
• MDR Text Key: 291620973
• Report Number: 3003504604-2022-00013
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124359
• UDI-Public: (01)07332414124359
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• 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?: Yes
• Date Manufacturer Received: 06/22/2022
• 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: MAHURKAR CATHETER; PRISMAFLEX SET
• Patient Outcome(s): Required Intervention
• Patient Sex: Male