MAUDE Adverse Event Report: CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) FILTER; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 21C0906

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hypovolemic Shock (1917); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/25/2021

Event Type  Injury  

Event Description

Patient on continuous renal replacement therapy (crrt), filter changed 3 times in one day.Filer clotted twice immediately after restarting.Patient was on heparin and acid-citrate-dextrose (pre blood pump) as well with no coagulation issues.The third time, restarting crrt had no issues and passed priming test.However, blood leak in the filter was alerted by the machine within 30 mins of restarting it.Pt was unstable while restarting crrt, had episodes of hypoxemic/hypovolemic shock, requiring high dose of vasoactive drugs, intravenous fluids and full ventilator support.Had to stop restarting crrt this time as the patient was not able to tolerate crrt.

• Brand Name: CRRT (CONTINUOUS RENAL REPLACEMENT THERAPY) FILTER
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• MDR Report Key: 14136715
• MDR Text Key: 291248284
• Report Number: 14136715
• 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: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 21C0906
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 28105 DA
• Patient Sex: Male
• Patient Weight: 83 KG