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

Catalog Number 955558

Device Problem Device Alarm System (1012)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/23/2021

Event Type  Injury  

Manufacturer Narrative

Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during continuous renal replacement therapy with a prismax control unit, an alarm condition related to filter pressure pod reposition failure occurred and the treatment was ended without the extracorporeal blood being returned to the patient.The amount of blood loss was not reported.No patient symptom was reported, however, it was a blood transfusion was performed.No additional information is available.

Manufacturer Narrative

H10: the actual device was evaluated on-site by a baxter qualified technician.A calibration of the automatic repositioning system (arps), pressure sensors and system self test were performed.The safety board and electrical connections were checked and reseated.The reported condition was verified.A prime test was performed and the device passed.A simulated treatment was performed for 30 minutes with no further alarms.A service history review was performed and revealed that the filter pressure pod was replaced after reoccurrence of the alarm.Should additional relevant information become available, a supplemental report will be submitted.

• 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 ; 2242702068
• MDR Report Key: 13289898
• MDR Text Key: 284020219
• Report Number: 3003504604-2021-00014
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412630359
• UDI-Public: (01)00085412630359
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2021
• Initial Date FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention