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 Blood Loss (2597)

Event Date 12/28/2020

Event Type  Injury  

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 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

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

The device was not returned and the lot number of the device was unknown; therefore, a sample analysis could not be completed.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: 11240059
• MDR Text Key: 229584307
• Report Number: 8010182-2021-00020
• 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: 12/30/2020,03/01/2021

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: 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: 01/29/2021; 02/26/2021
• Supplement Dates FDA Received: 02/24/2021; 03/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE
• Patient Outcome(s): Required Intervention