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

Device Problem Defective Device (2588)

Patient Problems Vascular System (Circulation), Impaired (2572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/23/2020

Event Type  Injury  

Event Description

On (b)(6) 2020.Delay in our ability to provide life-saving treatment of crrt contributed to continued decompensation of physiologic and hemodynamic stability, and worsening acid-base balance in this patient.A temporary hd catheter was placed at approx.(b)(6) at 2350.Crrt was to be initiated immediately to treat acute renal failure.Both prismax crrt machines, our machine and a baxter loaner machine displayed alarm "b1215 arps system failed".This alarm is a red alarm and would not allow for priming of the set and treatment could not be started.Both machines were turned off and attempts to reload the filter cartridge were made multiple times with the same alarm.I also attempted to use the manual tool on the back to override the alarm.Baxter icon line was called to determine if issue could be remedied.Baxter rep insisted that both machines be removed from service as this alarm signaled that an internal hardware issue was present.I requested that a stat service ticket be placed and stressed the importance of treatment for this patient.I requested that the loaner department be emergently paged to determine if an alternate machine could be delivered.The loaner department was unable to provide a loaner and stated that none were immediately available in the dfw area.Fda safety report id # (b)(4).

• Brand Name: PRISMAX CRRT MACHINE/BAXTER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 10958701
• MDR Text Key: 220247345
• Report Number: MW5098231
• Device Sequence Number: 2
• Product Code: KDI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening