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

Catalog Number	955792
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported during the setup of a prismaflex machine, the device base was observed to be loose when it connects to the main body of the machine.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Addition information: h10: the device was evaluated on site by a qualified baxter service technician.Visual inspection observed that the four screws holding the main body of the machine to the stand were loosened.The screws were tightened.Three photos and one video were inspected as well.One of the photos showed that out of the four inner screws holding the main body of the machine stand, two were partially unscrewed and made the man body loose on the stand.However, the video showed that the displacement of the body allowed by the unscrewed bolt was minimal and its extension wasn¿t able to cause the machine tilting over.The reported condition was verified.The cause could not be determined.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAFLEX
• Common Device Name: 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: 13359485
• Report Number: 9616026-2022-00011
• Device Sequence Number: 19244349
• Product Code: KDI
• UDI-Device Identifier: 07332414126766
• UDI-Public: (01)07332414126766
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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
• Operator of Device: Health Professional
• Device Catalogue Number: 955792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown