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

Catalog Number 955558

Device Problems No Display/Image (1183); Obstruction of Flow (2423)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that after an access pressure extremely negative alarm occurred, during continuous renal replacement therapy (crrt) with prismax machine, the machine screen froze.The filter set was observed to be clotted.Extracorporeal blood was not returned to the patient and a blood transfusion was required.No additional information is available.

Manufacturer Narrative

Correction added to b1 and h1.This event was deemed to be a serious injury event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Correction added to h6 (health effect).Additional information added to h3, h6 and h10.The actual device was evaluated on site by a clinical engineer and it was determined the event was the result of electronic failure of main printed circuit (pc) board.To resolve the issue, the pc board was replaced.A 48-hours simulated treatment test was successfully performed.The reported condition was verified.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• 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: 15759146
• MDR Text Key: 307693481
• Report Number: 3003504604-2022-00029
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124359
• UDI-Public: (01)07332414124359
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: No
• 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: NI.
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR