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

Catalog Number 955725

Device Problem No Audible Alarm (1019)

Patient Problems Air Embolism (1697); Loss of consciousness (2418)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

It was reported that during continuous renal replacement therapy (crrt) using an unspecified prismaflex set and an unspecified baxter crrt machine, a line became disconnected.It was alleged there was failure to adequately secure the patients lines.The patient reportedly developed an air embolism and lost consciousness.It was alleged the crrt machine failed to shut down to protect the patient from the embolism.The reporter stated every effort was made to aid in the patient¿s recovery.Eight days later, the patient reportedly died due to hypoxic ischemic brain injury.Attempts are ongoing to obtain the device history logs, serial number and device for further evaluation.No further information was available at the time of this report.

Manufacturer Narrative

The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

B5: upon follow up it was reported the event occurred while using a prismax machine and a prismaflex hf1000 set (previously reported as unknown).The access catheter line disconnected from the port when the patient was getting ready to attend a physical therapy session.At the time of the event, the patient had been in the hospital for 3-4 weeks to recover from another indication.D1: brand name: prismax machine.D4: catalogue #: 955725.D4: serial no.#: (b)(6).D10: concomitant product: prismaflex hf1000 set.G4: pma/510k #: na.H10: the device was not received for evaluation.The event history log review showed that the alarm condition related to the air bubble detected alarm was generated.The machine performed as expected stopping pumps and closing clamp, however, air was not removed by the user, and after ten minutes, the machine correctly alarmed alarm, stop, time, expired.The user selected ¿end treatment¿ and downloaded the set after more than one hour.The machine worked as per specification.A device history review revealed no issues that could have caused or contributed to the reported issue.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Based on additional information received, the prismax machine was determined not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINE
• 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 CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16980361
• MDR Text Key: 315734235
• Report Number: 1416980-2023-02495
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PRISMAFLEX HF1000 SET; UNSPECIFIED PRISMAFLEX DISPOSABLE
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Male