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

Catalog Number 114489

Device Problem Material Integrity Problem (2978)

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

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Facility name: (b)(6).Phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that during set up with a prismaflex machine, a loose wheel was noted.Further inspection observed that the left front wheel and the right rear wheel were damaged.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was evaluated by a qualified technician.It was determined during visual inspection that the left front wheel and the right rear wheel were damaged.To resolve the issues, the qualified technician requested for spare parts for replacement of the damaged wheels.The reported condition was verified.The cause could not be determined.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute 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: 11914149
• MDR Text Key: 263610618
• Report Number: 9616026-2021-00023
• Device Sequence Number: 1
• Product Code: KDI
• 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: 06/28/2021

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: 114489
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 06/01/2021
• Supplement Dates Manufacturer Received: 06/25/2021
• Supplement Dates FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1