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

Catalog Number 955626

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that clotting was observed in the prismaflex set during continuous renal replacement therapy using a prismax control unit.No ¿warning¿ was generated by the prismax device.There was blood loss and the extracorporeal blood was not returned to the patient.On the following day, the prismaflex filter was changed and clotting recurred.Extracorporeal blood was once again not returned to the patient.It was reported that the patient required a blood transfusion.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

H10: the actual device was not provided for evaluation, however, a picture was provided.Visual inspection verified that an alarm occurred and there was foam observed going up the return line and wetting the return barrier.The event history log review confirmed the occurrence of clotting filter alarms during both events.The system showed almost a nonstop generation of the negative pressure extreme alarm, indicating there may be something with the catheter in use that could be contributing to this.This alarm stops the blood pump, and any amount of time where the blood is sitting still, will increase clotting.The reported condition was verified.The device performed as expected, however, the cause of the condition could not be determined.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.

Manufacturer Narrative

Correction: removal of information in section f related to importer.The initial report inadvertently included the importer report number.This mdr should have been submitted only with the mfr.Number (and not as importer).

Manufacturer Narrative

Correction: b4/f8: date of this report in mdr follow up #2 is being corrected from blank to (b)(6) 2021.

• 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: 11240022
• MDR Text Key: 229091156
• Report Number: 1416980-2021-00217
• 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,Followup,Followup
• Report Date: 12/30/2020,07/29/2021

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/30/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 02/26/2021; 03/10/2021; 07/01/2021
• Supplement Dates FDA Received: 03/01/2021; 03/17/2021; 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX SET
• Patient Outcome(s): Required Intervention