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

Catalog Number 955626

Device Problem Device Alarm System (1012)

Patient Problem Blood Loss (2597)

Event Date 12/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during continuous veno-venous hemofiltration, a prismax machine generated unspecified types of alarms shortly after starting treatment.The alarms were followed by an alarm instructing the operator to "call service".The treatment was ended without the extracorporeal blood being returned to the patient.Blood loss was approximately 217ml.No patient symptom or need of medical intervention was initially reported; however, the hemoglobin concentration decreased and a blood transfusion was provided the following day.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

H10: the device was evaluated onsite by a baxter technician.The device passed a prime test, simulated run and self test.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A device history review revealed no issues that could have caused or contributed to the reported event.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
• MDR Report Key: 11095934
• MDR Text Key: 224395105
• Report Number: 1416980-2020-08198
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499(10)
• Combination Product (y/n): Y
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

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: 955626
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTO EFFLUENT SET; PRISMAFLEX M150 SET; PRISMASOL 2K BAGS; THERMAX POUCH; AUTO EFFLUENT SET; PRISMAFLEX M150 SET; PRISMASOL 2K BAGS; THERMAX POUCH
• Patient Outcome(s): Required Intervention
• Patient Weight: 105