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

Catalog Number ASKU

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Brand name: this report is against an unknown prismaflex set.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that air being pulled into the set while attached to the patient during continuous renal replacement therapy using a prismax machine and a prismaflex filter set.This resulted in multiple filter sets being used to continue with treatment.The blood pump segment was observed with large amount of air from an unknown source.It was reported that therapy was stopped and the patient was disconnected before air could reach them.As a result of the air, the filter sets clotted and the extracorporeal blood was not returned to the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Additional information: h6 and h10.H10: the device was not returned, and the lot number is unknown; therefore a device analysis could not be completed, however, the reported event is considered verified based on the log files analysis.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; deerfield IL
• MDR Report Key: 11239973
• MDR Text Key: 229582138
• Report Number: 8010182-2021-00019
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2020,03/05/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• 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; 03/01/2021
• Supplement Dates FDA Received: 03/01/2021; 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE.