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

Catalog Number 955433

Device Problem Break (1069)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter first name: (b)(6).Initial reporter last name: (b)(6).Initial reporter facility name: (b)(6).Initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during the installation, of a prismaflex machine, an unspecified issue was observed.Further inspection observed that the screw hole was crushed and the base could not be installed normally.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was evaluated on site by a qualified technician.Upon evaluation, the base of the machine was inspected, and it was noted that the screw hole was crushed; therefore, the base of the machine could not be installed.The reported condition was verified.The cause of the condition could not be determined.To resolve the issue, the qualified technician replaced the base.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 12536205
• MDR Text Key: 273601383
• Report Number: 9616026-2021-00054
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414123185
• UDI-Public: (01)07332414123185(21)
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

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 Catalogue Number: 955433
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2021
• Initial Date FDA Received: 09/27/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1