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

Catalog Number 955468

Device Problem Crack (1135)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Prismaflex st100 set c 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.The actual sample was not available for investigation.However, photos of the impacted unit were provided.The visual inspection of the provided pictures showed that the dialysate port was cracked.The reported condition was verified.The observed damage is typical of mechanical shock applied on the product leading to its breakage.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.

Event Description

It was reported that during use, one unit of prismaflex st100 set c had a crack on the rear side of the filter column.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: PRISMAFLEX SET (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: 16062250
• MDR Text Key: 308146466
• Report Number: 8010182-2022-00420
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 955468
• Device Lot Number: 22D0026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/28/2022
• 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