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

Catalog Number 955724

Device Problems Device Alarm System (1012); No Display/Image (1183)

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

Event Date 10/11/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the registered nurse tried to load three (3) oxiris filters onto the prismax v3 machine and kept getting the alarm "cannot detect set".The nurse tried a 4th filter and it loaded fine.Upon running the therapy session, the filter pressure began to rise quickly.The clinician hit the "stop" button and was attempting to perform a blood restitution when a call service alarm was triggered and ¿all the keys were grayed out¿, and the extracorporeal (ec) blood was not returned to the patient.The patient lost 220ml of blood and a blood transfusion with packed cells was required.No additional information is available.

Manufacturer Narrative

Additional information added to h6 and h10.H10: the device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.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 - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 15755214
• MDR Text Key: 303272285
• Report Number: 9616240-2022-00018
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/14/2022

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: 955724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/14/2022
• 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 SETS
• Patient Outcome(s): Required Intervention