MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PRISMAFLEX HF20; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 22B0046Z

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 08/04/2022

Event Type  malfunction  

Event Description

(b)(4).No harm - event reached patient, but no harm was evident.Manufacturer response for crrt filter hf20, hf20 filter (per site reporter) none as of yet.

• Brand Name: PRISMAFLEX HF20
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15257766
• MDR Text Key: 298226758
• Report Number: 15257766
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2022

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 Lot Number: 22B0046Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 730 DA
• Patient Sex: Female
• Patient Weight: 11 KG