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

Lot Number A6E2709M

Device Problem Use of Device Problem (1670)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/23/2023

Event Type  malfunction  

Event Description

Patient's caregiver reports that patient had increased clotting in head of dialyzer for two treatments in row after starting this new bottle of heparin.He reports that when he switched to a different bottle with a different lot # and that there was no longer any clotting issues.

• Brand Name: DIALYZER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• MDR Report Key: 16325980
• MDR Text Key: 309256780
• Report Number: MW5114786
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/03/2023

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 Lot Number: A6E2709M
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2023
• Patient Sequence Number: 1
• Treatment: HEPARIN SODIUM INJECTION
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White