MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX SETS (ST); DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107640

Device Problem Air/Gas in Device (4062)

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

Event Date 12/21/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after continuous renal replacement therapy (crrt) was started with two prismaflex st150 sets, ¿air was sucked into the filter¿ requiring the user to stop treatment and change the filter.Reportedly, the event occurred twice.It was further reported that the set was primed with no issues.The extracorporeal blood was not returned during both treatments.The amount of blood loss was not reported.The patient received one unit of packed red blood cells, 500ml crystalloid, and a norepinephrine infusion.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a companion sample was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing included load testing, pre-prime and priming testing, and self-testing, and the reported condition could not be reproduced.The reported condition was not verified in the companion sample.An event history log review was performed, and it was noted that there was air in the circuit that spread also in the return line.The reported condition was verified in the event history log.The cause of the reported condition could not be determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX SETS (ST)
• 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 - MEYZIEU; 7, av lionel terray, b.p. 126; meyzieu cedex rhone 69883 ; FR 69883
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18544426
• MDR Text Key: 333261539
• Report Number: 8010182-2023-00564
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414075651
• UDI-Public: (01)07332414075651
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/19/2024

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: 107640
• Device Lot Number: 23B0076CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRISMAX MACHINE
• Patient Outcome(s): Required Intervention