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

Model Number 955626

Device Problems Failure of Device to Self-Test (2937); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2020

Event Type  malfunction  

Event Description

Machine exhibited arps self-test failure on setup.Machine was being set up during rn training class -- not during patient care.Baxter educator reported problem to baxter service team.Upon replacement of arps tubing by baxter field tech, machine also failed return port negative pressure leak test -- return pressure port faulty and also needed to be replaced.Manufacturer response for continuous renal replacement therapy machine, prismaflex system for critical care (per site reporter).Baxter sales rep discussed issue with (b)(4).Baxter rep stated that faulty arps tubing noted to be source of problem, but stated that baxter would not repair machines until device exhibited yet another failure.However, due to safety concerns regarding potential failure while running on patient, icu leadership pulled machines from service.(b)(4) emailed service rep stating that zsfg expects all machines to be proactively repaired prior to putting back in service; awaiting response from baxter.

• Brand Name: PRISMAXPRISMAX SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 11036234
• MDR Text Key: 222313202
• Report Number: 11036234
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 955626
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2020
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1