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

Catalog Number 955626

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that an excessive fluid removal occurred during continuous renal replacement therapy while using a prismax for the first time in the facility.Instead of entering a patient fluid removal (pfr) of 110 ml/hour the nurse set the total replacement of 1400 ml as pfr.The patient became hypotensive and norepinephrine infusion was titrated up to improve the patient 's blood pressure (bp).The physician was notified and the pfr was then set to zero since over 900 ml had been removed from the patient.The patient was drowsy but remained alert and oriented and on nasal cannula oxygen.The bp improved with pfr set at zero and increased norepinephrine dose.No additional information is available.

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).

Manufacturer Narrative

Additional information: h6 and h10.H10: the device was not received for evaluation, however, the reported event of use error of entering the patient fluid removal value of 110 ml/hour instead of 1400 ml/hour was confirmed based on customer report.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: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10976943
• MDR Text Key: 220472863
• Report Number: 1416980-2020-07653
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499(10)
• Combination Product (y/n): Y
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2020
• Event Location: Hospital
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTO EFFLUENT SET; PRISMAFLEX M150; PRISMASOL 2K/3.5CA; THERMAX POUCH; AUTO EFFLUENT SET; PRISMAFLEX M150; PRISMASOL 2K/3.5CA; THERMAX POUCH
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 61