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

Catalog Number 955626

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: the patient's exact age was not reported; however, the patient was reported to be in their 80s.1416980-2021-04762 was submitted to the fda for the first machine.This mdr refers to the second machine.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that two extracorporeal circuits of blood were not returned to the patient during continuous renal replacement therapy (crrt) using prismax machines.The first treatment with the first machine was interrupted without the extracorporeal (ec) blood being returned to the patient due to clot formation in the catheter.The catheter was replaced with a new 15 cm long non-baxter catheter located in the right femoral vein.The second treatment with the second machine was running for fifteen minutes before a ¿return pressure negative¿ alarm was generated.Troubleshooting was unsuccessful and an alarm was generated informing the operator that the blood pump had been stopped for too long.The ¿blood return¿ function was allegedly greyed out and treatment was once again terminated without blood return.No patient symptom or medical intervention was reported at this time.No additional information is available.

Manufacturer Narrative

Correction: cfn/fei# 3003504604.H10: the device was not received for evaluation, however seven (7) photographs and two (2) videos were provided for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A device history review revealed no issues that could have caused or contributed to the reported issue.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.The prismax machine operated as intended.The reported alarms were likely due to user error (the return pressure being set to an unrealistically low value).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
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; 7601 northland drive; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12270547
• MDR Text Key: 264855301
• Report Number: 1416980-2021-04764
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2021
• 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: AUTO EFFLUENT SET; PRISMAFLEX M150 SET; THERMAX; AUTO EFFLUENT SET; PRISMAFLEX M150 SET; THERMAX
• Patient Sex: Male
• Patient Weight: 61 KG