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

Catalog Number 955558

Device Problem No Display/Image (1183)

Patient Problem Blood Loss (2597)

Event Date 12/07/2019

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 renal replacement therapy with citrate anticoagulation, using a prismax machine equipped with the theramex blood warmer and a prismaflex oxiris set, the prismax machine screen became blocked.The treatment was interrupted and the estimated blood loss of 300 ml was not restituted to the patient.The patient was transfused with two packed red blood cells.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Additional information added: h10: the device was serviced by a qualified technician.The cause of the reported blocked screen was determined to be manufacturing related.A nonconformance has been opened to address the reported leaking effluent bag.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: h6 and h10.The device was not received for evaluation.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 issue.The reported issue 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
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9544919
• MDR Text Key: 183538279
• Report Number: 3003504604-2019-00009
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXIRIS SET; THERMAX BLOOD WARMER UNIT
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR