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

Catalog Number	955542
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Importer report number - (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the wheel of a prismaflex machine was observed to be broken.This event happened before patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information added to h3, h6 and h10.H10: the actual devices was evaluated on site by a qualified technician.Upon visual inspection, the reported problem of faulty wheel was confirmed.The cause could not be determined.To resolve the issue, the qualified technician replaced the wheel.The device passed the prime test and successfully completed the simulated treatment and self test.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 - LUND MONITORS; deerfield IL
• MDR Report Key: 9983837
• Report Number: 9616026-2020-00015
• Device Sequence Number: 3676341
• Product Code: KDI
• UDI-Device Identifier: 07332414124236
• UDI-Public: (01)07332414124236
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K131516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020
• Report Date (Section F): 04/21/2020

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: 955542
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/21/2020
• Event Location: Other
• Date Report to Manufacturer: 04/21/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 04/21/2020
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/21/2020