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

Catalog Number 107640

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

It was reported an external water leak was observed originating from the ¿screwed connector¿ due to rupture of a prismaflex st150 set during prime.There was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

The device was received for evaluation.During visual inspection, the return screwed connector was observed cracked.The reported condition was verified.The cause of the condition could not be determined.However, the most probable cause was due to shock during shipping.The observed damage is typical of mechanical shock applied on the product leading to its breakage.The exact moment and location where the shock occurred could not be determined.A product with such damage would have been detected during the manufacturing plant¿s 100% in process visual control & leak test.The cause of the event was due to a manufacturing issue.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: 17108371
• MDR Text Key: 317508667
• Report Number: 8010182-2023-00207
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414075651
• UDI-Public: (01)07332414075651
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107640
• Device Lot Number: 22I0103CD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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