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

Model Number M150

Device Problems Complete Blockage (1094); Defective Component (2292)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/14/2022

Event Type  Death  

Event Description

Patient: deceased.Product impact: no indication product failure caused patient death.However, because clotted blood cannot be returned this does have a negative impact on patient care.Previous occurence: product already reported to fda as possibly defective; this is a second report.Previous report on (b)(6) 2022.Note this occurrence happened on a different patient.Clinical notes: on (b)(6) 2022 at 2111, patient clotted off crrt filter (lot 21l0010ce), requiring the circuit to be changed.On (b)(6) 2022 at 0332 the patient again clotted off his filter (same lot #, 21l0010ce).Patient again clotted on (b)(6) 2022 at 0900 requiring the circuit to be changed (using new lot # for this change).Additional notes from clinicians: catheter was flushed frequently.No anticoagulant utilized.Other contributors to event: materials management quarantined the lot as we suspected it was a bad lot based on our previous event on (b)(6) 2022.However, we received more product from the distributor which was the same lot number as before, which we failed to quarantine, thus resulting in our hospital using this lot again.This is a total of 6 occurrences of alarming and clotting with this particular lot and no failures with other products with different lot numbers.Fda safety report id # (b)(4).

• Brand Name: BAXTER PRISMAFLEX M150
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 15076488
• MDR Text Key: 296403650
• Report Number: MW5111010
• Device Sequence Number: 2
• 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: 07/19/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M150
• Device Catalogue Number: 109990
• Device Lot Number: 21L0010CE
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White