MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION BAXTER PRISMAFLEX M150 CRRT FILTER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number M150

Device Problems Increase in Pressure (1491); Defective Component (2292); Obstruction of Flow (2423); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2022

Event Type  Death  

Event Description

Patient undergoing crrt (continuous renal replacement therapy) in the intensive care unit (icu) follow up notes: patient deceased (dnr); clinical opinion: cause of death not result of defective equipment; clotting and delay of treatment might be a contributing factor to the adverse event; evidence suggest lot is defective based on problem occurred three times with particular lot number but not with any other lot number, no deviation to clinical procedure.Point of contact (poc) listed in fda form is for the recall administrator.Any clinical follow up is preferred to be conducted with icu.Manager email address: (b)(6).Additional notes: have not contacted the manufacturer yet.Will contact after form fda 3500 completed.Currently in possession of 5 unused filters with the affected lot number.Do not have the used product to return to the company.Event details (clinical notes): (b)(6) 2022 started crrt at 1100 this am.About an hour after initiation, repeatedly got high pressure alarms on access, return, effluent and filter.Stopped treatment, returned blood and started a new set.About 20 minutes into new treatment, pressures again climbed to 200- 300.Called prismaflex help line and after talking through the alarms and troubleshooting, i was advised to reverse the lines.After reversing the lines, crrt ran smoothly with normal pressures for about an hour.It then began alarming filter clogging and high access pressure.Attempted to flush access line but due to difficulty, pulled back and aspirated a clot.After disconnecting the return line noted a large clot in that line as well.Stopped crrt and was not able to give blood back due to obvious clots.Discussed with dr.(b)(6).Per dr.(b)(6), will hold crrt tonight and resume tomorrow with citrate.On (b)(6) 2022 1130 started crrt with citrate (pre-filter) and calcium chloride (systemically).Within 15 minutes of infiltration had to stop treatment due to high return line with transmembrane pressures (tmp pressures), pulled a clot out of return line when disconnected and aspirated another clot out of return catheter on patient line.Unable to return blood due to clots; 1400 new orders to start crrt back up with an increased rate of citrate and reversing.Within 10 minutes of starting treatment, access pressures were elevated with clots visible in the crrt line.Stopped treatment immediately.Fda safety report id# (b)(4).

• Brand Name: BAXTER PRISMAFLEX M150 CRRT FILTER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 14885182
• MDR Text Key: 295232114
• Report Number: MW5110626
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/28/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M150
• Device Catalogue Number: 109990
• Device Lot Number: 21L0010CE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White