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

Catalog Number 955558

Device Problem Protective Measures Problem (3015)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during continuous renal replacement therapy (crrt) using a prismax machine, a patient experienced blood loss, resulting in a blood transfusion.Upon initiation of therapy a ¿syringe not detected¿ alarm occurred.The syringe was unloaded and reloaded, but the alarm persisted.The user also observed "small air bubbles" in the "replacement line running along the side the arterial line".Troubleshooting attempt was successful.Air was additionally observed in the arterial line, that was allegedly "causing froth due to intermittent extreme negative pressure alarms".The alarm for access pressure extremely negative was associated with a "problematic" vascular catheter.The alarm was resolved and treatment was continued, however, each time this alarm was triggered, a vacuum of air was generated by the negative pressure within the access line resulting in micro air bubbles to form when it came in contact with blood in the line.It was reported that the filer clotted resulting in a blood loss of approximately 250 ml as the machine would not allow the nurses to return the patient's blood.The nurses made a second attempt at getting the patient up and running on crrt and all the same problems happened again resulting in further patient blood loss (approximately 250 ml).A blood transfusion was performed.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

The device was not received for evaluation.An event history log review was performed, and the reported events were verified.The cause of the condition could not be determined.A service history review was performed and revealed that one similar event occurred.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
• 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: 13177926
• MDR Text Key: 288496083
• Report Number: 3003504604-2021-00012
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414124359
• UDI-Public: (01)07332414124359
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 03/17/2022
• 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: Initial
• Patient Sequence Number: 1
• Treatment: VASCULAR CATHETER
• Patient Outcome(s): Required Intervention