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

Catalog Number	955626
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional 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.This mdr refers to the first machine.A second mdr will be submitted to the fda for the second machine.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem 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.
Additional 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 reported condition was not verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX
• Common Device Name: 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: 12270566
• Report Number: 1416980-2021-04762
• Device Sequence Number: 5244830
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K190910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AUTO EFFLUENT SET; PRISMAFLEX M150 SET; THERMAX
• Patient Sex: Male
• Patient Weight: 61 KG