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

Catalog Number 107493

Device Problem Break (1069)

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

Event Date 06/10/2022

Event Type  malfunction  

Event Description

It was reported that a broken wheel was observed on a prismaflex machine during setup.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h3, h6 and h10.H10: the device was evaluated on site by a qualified technician who confirmed the reported problem.During evaluation, the qualified technician noted that the wheel was damaged thus replaced the same to resolve the issue.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 MACHINES
• 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 - LUND MONITORS; magistratsvagen 16; lund skane lan SE-22 643; SW SE-22643
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14914785
• MDR Text Key: 303554141
• Report Number: 9616026-2022-00064
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K072093
• 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: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1