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

Catalog Number 955558

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a prismax machine inaccurately delivered heparin during continuous renal replacement therapy.The machine ¿had bolused heparin syringe of approximately 10 to 15mls into patient's blood 'spontaneously' ¿.The treatment was ended without the extracorporeal blood being returned and the patient's clotting factors were within normal limits an hour later.There was no report of medical intervention with this event.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, photographs were provided for evaluation and the machine was evaluated on-site by a baxter qualified technician.Visual inspection of the photos showed the device monitor which detailed four (4) hours of the affected treatment.The technician performed machine testing and all functionalities, including the syringe pump, were found to be within specification.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 of inaccurate delivery was verified.The cause of the condition was determined to be related to use error, as the log file investigation concluded that negative pressure was caused by the syringe piston not being locked or completely locked, which may have resulted in an uncontrolled heparin bolus.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 - BROOKLYN PARK; 7601 northland drive; n suite 170; minneapolis MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19097564
• MDR Text Key: 340796847
• Report Number: 3003504604-2024-00007
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 955558
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/14/2024
• 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
• Treatment: HEPARIN; PRISMASOL
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 78 KG