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

Catalog Number	955626
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during continuous renal replacement therapy using a prismax machine, the patient received a heparin bolus as a result of the syringe emptied completely when changing the syringe.The event occurred after multiple alarms were generated including bag empty; access disconnection; effluent line clamped; heparin syringe empty.It was further reported the nurse attempted to reinstall the same syringe.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Initial reporter phone no: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information added to h6 and h10.H10: the device was not received for evaluation; however, the machine was evaluated by an on-site technician.The technician noted alarms were stacked and included bag empty, access disconnection, effluent line clamped, heparin syringe empty.The customer attempted to reinstall the same syringe and the syringe arm did not stop at the plunger and delivered the contents of the syringe into the circuit.The syringe line should have been clamped during changing syringe.This alarm is unlikely to occur in case the syringe piston is locked as prescribed.However, the biomed didn¿t report any defect or anomaly of the machine was found during the evaluation.Per the operator manual, on "anticoagulation" chapter, "for systemic anticoagulation, to infuse anticoagulant between the blood pump and the filter, connect the syringe to the syringe line on the disposable set.Stow the syringe line on the disposable set along the left side of the set cartridge.Clamp the syringe line when changing the syringe.When the syringe is installed, follow the onscreen instructions to unclamp the syringe line.The syringe flow cannot be changed during a syringe change".The reported condition was verified.The cause of the condition was due to a user error.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.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX MACHINES
• Common Device Name: 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: 16095189
• Report Number: 3003504604-2023-00001
• Device Sequence Number: 6529321
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K190910
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown