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

Catalog Number 955468

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

Patient Problem No Patient Involvement (2645)

Event Date 07/12/2020

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. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The actual device was not available; however, a photograph of the sample was provided for evaluation. The visual inspection of the provided picture showed a fluid leak at the level of the male luer lock of a cracked access line. The cause of the reported issue was design related. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during the priming of a prismaflex st100, an external fluid leakage was observed from a rupture inside the luer connector. There was no patient involvement. 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 60073 ; 2242702068
• MDR Report Key: 10370763
• MDR Text Key: 222336367
• Report Number: 8010182-2020-00120
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955468
• Device Lot Number: 19E2102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/12/2020
• 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: Unkown