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

Catalog Number 955626

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that during veno-venous hemofiltration therapy using a prismax control unit and a prismaflex m150 set, a patient became hypotensive and was treated with norepinephrine and vasopressin.It was reported that the patient was in the intensive care unit and on a ventilator support at 100% and experiencing atrial fibrillation with rapid ventricular rate.Within a few minutes of connecting the patient, the blood flow rate (bfr) too low for thermax alarm and an unable to detect return alarm occurred.The bfr was increased from 100 ml/min to 150 ml/min resolving both alarms.At an unspecified time during treatment, the prismax machine generated alarms related to ¿access extremely negative¿ and ¿tmp increasing¿ and troubleshooting attempts failed to solve the conditions.The operator attempted to return the extracorporeal blood to the patient, but the blood return function on the prismax was reportedly not available.The treatment was terminated without returning the extracorporeal blood to the patient.The patient was reportedly hemodynamically unstable (no blood pressures provided) and the vasopressor medication was increased and phenylephrine was added.The patient outcome was not reported.No additional information is available.

Manufacturer Narrative

H10: the device was inspected on-site by a qualified technician.A prime test, a simulated run and a self test.Were performed and the device passed all tests.No device malfunction was observed.An event log review was performed and the reported alarms were verified.Once the cause of the alarms was identified, the proper interventions were taken.It has been determined that the prismax operated as intended.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PRISMAX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11095153
• MDR Text Key: 224360618
• Report Number: 1416980-2020-08185
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00085412639499
• UDI-Public: (01)00085412639499(10)
• Combination Product (y/n): Y
• PMA/PMN Number: K190910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 955626
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AUTO EFFLUENT SET; EFFLUENT BAG; PRISMAFLEX M100 SET; PRISMASOL; THERMAX POUCH; AUTO EFFLUENT SET; EFFLUENT BAG; PRISMAFLEX M100 SET; PRISMASOL; THERMAX POUCH
• Patient Outcome(s): Required Intervention
• Patient Weight: 105