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

Catalog Number	955542
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that approximately one hour into continuous veno-venous hemodialysis using a prismaflex control unit and a prismaflex m100 set, a 'main power lost alarm' was generated, followed by a ´malfunction: voltage out of range' alarm.It was reported that the prismaflex was plugged in securely to the red outlet.The treatment was ended without the extracorporeal (ec) blood being manually returned to the patient as clots were observed in the tubing.The amount of blood loss was not reported.It was reported the a blood transfusion was administered to patient.Further inspection observed that the plug connecting the power cord to the prismaflex machine inside the black plastic connector was not all the way plugged in to the back of the machine.This was corrected and treatment was re-started without further incidents.No additional information is available.
Additional Manufacturer Narrative
H10: 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
• Common Device Name: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10574908
• Report Number: 9616026-2020-00027
• Device Sequence Number: 3735129
• Product Code: KDI
• UDI-Device Identifier: 07332414124236
• UDI-Public: (01)07332414124236(21)
• Combination Product (Y/N): Y
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020
• Report Date (Section F): 09/23/2020

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: 08/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX M100; PRISMAFLEX M100.
• Date Report Sent to FDA: 09/23/2020