MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SEPXIRIS 150; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 955617

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 01/21/2021

Event Type  malfunction  

Manufacturer Narrative

Prismaflex sepxiris set 150 (jp) is similar to prismaflex st150 set, prismaflex st150 set ckt, and prismaflex st150 set c.Prismaflex st150 set, prismaflex st150 set ckt, and prismaflex st150 set c have 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.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during priming, an external fluid leak was observed from a crack on the one-way valve of the heparin line from a sepxiris 150.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information added.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SEPXIRIS 150
• 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: 11327826
• MDR Text Key: 245090988
• Report Number: 8010182-2021-00049
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124618
• UDI-Public: (01)07332414124618
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2021

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: 12/01/2021
• Device Catalogue Number: 955617
• Device Lot Number: 19L1005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/21/2021
• Initial Date FDA Received: 02/15/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/11/2021
• 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: Unknown
• Patient Sequence Number: 1