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

Catalog Number 955626

Device Problems Protective Measures Problem (3015); Air/Gas in Device (4062)

Patient Problems Anemia (1706); Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, following fifteen(15) minutes of continuous renal replacement therapy (crrt) using a prismax machine and a prismaflex m150 set, the patient's blood pressure decreased from 100/50 to 40/20 mmhg. Medical intervention, including titrating up vasopressors, was provided. An ¿air in blood¿ alarm was then generated and large amount of air was reportedly seen at the top of the m150 filter along with foam. The treatment was terminated without returning the extracorporeal (ec) blood to the patient. A blood loss of 217 ml was reported. An unspecified bolus of fluid replacement was provided together with albumin and, following decrease of hemoglobin from 8. 8 to 7. 2 g/dl, a blood transfusion was prescribed. No additional information is available.

• Brand Name: PRISMAX
• 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 - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12259358
• MDR Text Key: 264504773
• Report Number: 1416980-2021-04695
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 08/02/2021 Patient Sequence Number: 1

Treatment

AUTO EFFLUENT SET; NORMAL SALINE; PRISMAFLEX M150 SET; THERMAX; THERMAX POUCH