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

Model Number 955542

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Event Description

(b)(4).Baxter prisma flex hemodialysis units.Per baxter request we have downloaded your form.The alert has been sent out to nursing mgmt to inform staff to not use extension tubing for covid 19 pts on any pts due to possible issues.(b)(6), lead biomed tech.(b)(6) 2020.

• Brand Name: BAXTER PRISMAFLEX HEMODIALYSIS
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 9962015
• MDR Text Key: 187747393
• Report Number: MW5094129
• Device Sequence Number: 5
• 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
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Device Operator: No Information
• Device Model Number: 955542
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1