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

Catalog Number 955792

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Blood Loss (2597)

Event Date 01/13/2021

Event Type  Injury  

Manufacturer Narrative

Facility name: (b)(6) hospital. Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a pediatric patient became hypotensive and experienced tachycardia approximately two hours after starting continuous renal replacement therapy using a prismaflex control unit and a prismaflex m60 filter. The patient was treated with a fluid bolus and one dose of calcium. The patient's condition was reported to have stabilized. On the same day, reported as later in the evening, a check return alarm, immediately followed by a return disconnection alarm and then immediately followed by an air in blood alarm was generated by the prismaflex control unit. No disconnection or air in the return line was observed. The air in blood alarm could not be cleared and the nurse was unable to hit stop during the air in blood alarm. The machine was turned off and the blood was not returned. The amount of blood loss was not reported. The patient was re-connected to a new prismaflex control unit to continue with treatment. No additional information is available.

• Brand Name: PRISMAFLEX
• Type of Device: 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 60073 ; 2242702068
• MDR Report Key: 11290580
• MDR Text Key: 231574459
• Report Number: 9616026-2021-00005
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K131516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 955792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 02/07/2021 Patient Sequence Number: 1