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

Catalog Number 955468

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.Prismaflex st100 set c 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 an external blood leak was observed from a cut in the return line of a prismaflex st100 set during continuous renal replacement therapy.The amount of blood loss was not known.There was no report of medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H11: the actual device was not available; however, photographs of the sample were provided for evaluation.Visual inspection of the photos showed a perforation in the return line.The presence of blood in the return line indicated that the hole was not present during priming.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.The cause of the damage was determined to be related to improper handling of the product during use.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: 19118897
• MDR Text Key: 340302510
• Report Number: 8010182-2024-00173
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123468
• UDI-Public: (01)07332414123468
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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 Catalogue Number: 955468
• Device Lot Number: 23C0038CB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/29/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/14/2024
• Supplement Dates FDA Received: 05/22/2024
• 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