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

Catalog Number 955558

Device Problem Device Alarm System (1012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that five hours into continuous renal replacement therapy treatment with a prismax machine, a ¿arps¿ (self-test failure) alarm was generated.The treatment was interrupted and an estimated blood loss of approximately 186 ml was recorded.Extracorporeal blood return was not performed.Treatment was continued using another prismax machine and hf1400 set.However, after a few hours into treatment, an arps alarm was also generated by this prismax machine and treatment was once again terminated without blood return.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information added: b5, h3, h6 and h10.B5: the amount of blood loss was reported as 186 ml.H10: the prismax device was evaluated on site by a qualified baxter technician.The technician carried out arps system self test (sst ), and the error was duplicated.The arps pump tube with filter was replaced.The qualified technician calibrated and carried out another sst to all pressure sensors without any issues and also preventively calibrated the scales before returning the device to service.The event history lox files was reviewed and the reported issue was observed.The reported condition was verified.A device history review revealed no issues that could have caused or contributed to the reported event.The reported issue is being further investigated by the manufacturer.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: 10260660
• MDR Text Key: 198506263
• Report Number: 1416980-2020-03911
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412630359
• UDI-Public: (01)00085412630359
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 07/10/2020,09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/10/2020
• Distributor Facility Aware Date: 06/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/10/2020
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMINO TRANSFORM CONVERTER; PRISMOCITRATE; SET HF1400; THERMAX BLOOD WARMER DISPOSABLE; THERMAX BLOOD WARMER UNIT