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

Catalog Number	955792
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that rapidly reoccurring "excessive tmp" alarms was generated on a prismaflex machine during pediatric continuous renal replacement therapy.Treatment was discontinued and before the therapy was restarted, the patient became bradycardic and severely hypotensive.Resuscitation fluids was provided.The patient was recovering in the intensive care unit.No additional information is available.
Additional Manufacturer Narrative
Correction: removal of information in section f related to importer - the initial report inadvertently indicated that the report was being submitted as an importer report.This mdr should have been submitted only as a manufacturer report (and not as an importer report).
Additional Manufacturer Narrative
Additional information added to h3, h6 and h10.H10: the device was inspected on site by a qualified baxter technician.A service history review was conducted and three repairs related to tmp excessive alarms were identified.The first was resolved by calibration of the pressure pods and the other two involved a replacement of the automated re-positioning system (arps) tubing.The reported condition was verified through analysis of the event history log.Visual inspection of the device determined that the arps pump tubing was broken and it was replaced to resolve the 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
• MDR Report Key: 11095344
• Report Number: 9616026-2020-00040
• Device Sequence Number: 3756266
• Product Code: KDI
• UDI-Device Identifier: 07332414126766
• UDI-Public: (01)07332414126766(21)
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 955792
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 01/28/2021; 03/18/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/22/2021; 03/23/2021
• 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 HF1000
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 4