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

Catalog Number 955725

Device Problem Filling Problem (1233)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during continuous renal replacement therapy with a prismax machine multiple alarms were triggered.According to the reporter, while troubleshooting the alarms, a complete heparin syringe was automatically administered to the filter.As a result, the patient was given protamine and unspecified blood tests were performed.The results were reported as "parameters were normalized within 24 hours".No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, the machine was evaluated on-site by a baxter qualified technician following the guidelines of the service manual.Functional testing of the syringe pump was performed, and the self-test passed.Simulated treatment was completed successfully.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the condition was determined to be related to use error, as the log file investigation concluded that negative pressure of the return was transmitted to the filter and to the syringe.A syringe plunger left unlocked by the user can allow anticoagulant fluid to be drawn into the extracorporeal circuit and result in an uncontrolled administration of heparin.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• 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 - MEDOLLA MODENA MONITORS; via modenese, 66; medolla modena 41036 ; IT 41036
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18979355
• MDR Text Key: 338611176
• Report Number: 9616240-2024-00004
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/16/2024

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: 955725
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 05/13/2024
• Supplement Dates FDA Received: 05/16/2024
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female