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 Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Blood Loss (2597); Bronchospasm (2598)

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 within 30 minutes of restarting continuous renal replacement therapy with a new prismaflex control unit, a pediatric patient experienced bronchospasm, hypotension and tachycardia in the 160s. The pre blood pump prescription was increased and the patient was given a fluid bolus and two doses of calcium. The patient's condition stabilized. Shortly afterwards, "the patient was at full flows on the circuit per prescription" and the patient began to show clinical signs of change. Approximately twenty minutes later, the machine alarmed with return disconnection and filter clotting. At this time, the patient started seizing, experienced bradycardia, and became hypotensive. At this time, the patient's pupils were observed to be fixed and no pulse was palpable. Treatment was terminated and blood was not returned to the patient. Amount of blood loss was not reported. Cardiopulmonary resuscitation was performed for 45 minutes before the patient stabilized and was placed on extracorporeal membrane oxygenation. 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: 11290581
• MDR Text Key: 231575447
• Report Number: 9616026-2021-00006
• 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