MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX ST100; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115309

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter last name: (b)(6).Initial reporter address: (b)(6).Initial reporter city: (b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.Prismaflex st100 set ckt has been temporarily approved for use in the us under emergency use authorization eua(b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.

Event Description

It was reported that during treatment with a prismaflex st100 set, a fluid leakage was noted due to a defective connection.This issue was further described as, ¿the defect that caused leakage was the connection part of the blue line went wrong¿.There was patient involvement but no patient impact and no medical intervention.No additional information is available.

• Brand Name: PRISMAFLEX ST100
• 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: 13048269
• MDR Text Key: 284189726
• Report Number: 8010182-2021-00410
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414118389
• UDI-Public: (01)07332414118389
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 115309
• Device Lot Number: 21G1104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2021
• 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: NI.