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

Catalog Number 107640

Device Problems Break (1069); Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization eua200704 to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the line of a prismaflex st150 set became disconnected during continuous venovenous hemodiafiltration therapy.A small part of the internal plastic lumen broke off and was stuck inside the venous access catheter.There was no report of patient injury or medical intervention associated with this event.No additional information available.

Manufacturer Narrative

H10: the following was received by the customer.A photograph and a drawing of the sample were provided for evaluation.Visual inspection showed that the cone of the access male luer lock was broken.These components are provided preassembled by a baxter supplier.The reported condition was verified.The cause of the broken luer connector was determined to be related to supplier product design and manufacturing.A corrective action preventive action record and a change control were previously opened to address this issue.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: 19013438
• MDR Text Key: 339037719
• Report Number: 8010182-2024-00130
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: N/A
• 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: 05/08/2024

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: Other
• Device Catalogue Number: 107640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 05/03/2024
• Supplement Dates FDA Received: 05/08/2024
• 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
• Treatment: GAMCATH HIGHFLOW TRIPLE CATHETER