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

Catalog Number 955626

Device Problem Filling Problem (1233)

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

Event Type  malfunction  

Event Description

It was reported heparin was incorrectly delivered from a prismax machine.During hemodialysis therapy ¿the entire syringe¿ (volume was not reported) of heparin was bloused within two hours.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

B3: the date of the event was reported as an unspecified date in (b)(6) 2023.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information added to h6 and h10.B5 correction: during hemodialysis therapy ¿the entire syringe¿ (volume was not reported) of heparin was bloused within two hours.H10: the device was not received for evaluation; however, the machine was evaluated on-site by a baxter technician.External inspection was performed and no issues were noted.The technician proactively calibrated the syringe pump and completed a successful syringe pump system self-test (stt).Completed a successful syringe pump sst.Setup the machine for a simulated treatment.During review of the log files, the return pressure suddenly dropped down to 0 mmhg at 17:06:23 and the prismax issued an alarm t0525 ¿return pressure drop¿.The filter pressure concurrently went down to -155 mmhg.As a result, the negative filter pressure, which was transmitted to the syringe, the prismax issued an alarm t1298 ¿syringe force low¿.This alarm stops the anticoagulant infusion; the user decided to restart the treatment and to reload a new syringe content (at 17:07).The user decided to end the treatment at 17:45.The reported condition was verified.The cause of the condition could not be determined; however, the most probable cause was due to a user error over-delivery of heparin.The over delivery was likely associated to the negative pressure at the outlet of the syringe tubing.The negative pressure, if the retainer of the plunger clip of the syringe piston wasn¿t locked or it was incompletely locked, may have resulted in an uncontrolled heparin delivery.Per the operator manual, ¿connecting sets and fluids ¿ syringe¿ chapter, instructs the user that the ¿syringe installation is complete when the syringe test pass and the plunger clip is closed¿.In addition, the section - systemic anticoagulation ¿ requires that the user - when changing the syringe ¿ shall closing the plunger clip lock.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
• 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; suite 170; brooklyn park MN 55428
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17067380
• MDR Text Key: 316615906
• Report Number: 3003504604-2023-00013
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 06/05/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 07/11/2023
• 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