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

Catalog Number 955558

Device Problem No Visual Prompts/Feedback (4021)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Blood Loss (2597)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

The prismax device was evaluated on site by a qualified baxter technician.A calibration and system self-test (sst) were performed with no further issues reported.Scheduled preventive maintenance (pm) was also executed.The return pressure sensor was replaced.The reported problem was verified.The event history log review was performed and it confirmed the occurrence of a technical alarm b1116: ¿return pressure self - test fail¿, as intended after a failed pod reposition and requiring the return pressure sensor to be changed.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause was a faulty pressure sensor.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a pediatric patient experienced arterial hypotension and hypoxia during a continuous renal replacement therapy treatment, using a prismax machine and a prismaflex hf20 set.It was reported that the prismax machine generated an alarm: b1116: ¿return pressure self - test fail¿ and the screen became black.This error code was preceded 15 minutes before by alarm t0525 (return disconnection).The treatment was ended with only part of the extracorporeal blood being returned to the patient using the hand crank.During the change of circuit, the pediatric patient was in arterial hypotension and hypoxic which required refilling by supply of platelets and plasma.At the time of this report, the patient has recovered from the event.No additional information is available.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 11149326
• MDR Text Key: 226111544
• Report Number: 1416980-2020-08440
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX HF20 SET
• Patient Outcome(s): Required Intervention
• Patient Weight: 3