MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 107640

Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)

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

Event Date 12/19/2021

Event Type  Injury  

Manufacturer Narrative

Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a prismaflex st150 set clotted during continuous renal replacement therapy following multiple access related alarms generated by the prismax machine.Blood was not returned to the patient and the amount of blood loss was not reported.The patient was reported to have been very unwell and blood transfusion was provided as hemoglobin was 72.A new treatment was initiated but this was also associated with access related problems and air was observed in the extracorporeal circuit at the junction of the pbp line with the access blood line.Attempts to correct the chamber fluid level and clear the alarms were unsuccessful and the prismaflex st150 set clotted.No additional information was provided.

Manufacturer Narrative

Additional information: h3, h6 and h10.H10: the device was not returned for evaluation; however, one photograph and two videos were provided for evaluation.Based on visual inspection of the photograph and videos, air was observed in the extracorporeal circuit at the junction of the pbp line with the access blood line.The cause of the 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 ST150
• 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 ; 2242702068
• MDR Report Key: 13472460
• MDR Text Key: 285184204
• Report Number: 8010182-2022-00017
• Device Sequence Number: 1
• Product Code: KDI
• 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
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2022
• 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: 21E2202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2022
• 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