MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEYZIEU PRISMAFLEX M100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 106697

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)

Event Date 02/17/2020

Event Type  Injury  

Manufacturer Narrative

Lot number - the customer reported lot number 1812101; however, this lot number is not recognized by baxter.The lot number in the facility's omnicel (not specified what an omnicel is) was reported as 19j2804.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A continuous renal replacement therapy patient coded and experienced a drop in blood pressure during treatment with a prismaflex m100 and a prismaflex machine.It was reported that patient received treatment, however, the treatment received was not specified.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.The reported condition was not verified and the cause is unknown.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX M100
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - MEYZIEU; deerfield IL
• MDR Report Key: 9836855
• MDR Text Key: 188647256
• Report Number: 8010182-2020-00017
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K041005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/16/2020,03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 106697
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2020
• Distributor Facility Aware Date: 02/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2020
• Date Manufacturer Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX MACHINE
• Patient Outcome(s): Other