MAUDE Adverse Event Report: FRESENIUS USA, INC. 2008 SERIES HEMODIALYSIS MACHINES; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 2008K2

Device Problems Therapeutic or Diagnostic Output Failure (3023); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

Patient regularly receives continuous renal replacement therapy (crrt) in his patient room.At approx.0015 this am, i attempted to rinse back patient's treatment from crrt machine, as his 12-hour therapy was stated to terminate within the next 15 minutes.I was able to successfully rinse back his arterial side, but as soon as i switched over to rinse back the venous side, the screen of crrt machine froze and would not allow any inputs, resets, silencing, or rinsing back.Every imaginable intervention to rinse back the venous side was attempted, but my patient was unable to receive back the portion of his blood that was in the venous side of the machine.I informed md of what occurred, who voiced concerns about the patient continuing to receive crrt on that machine.I also consulted with the dialysis rn, who stated that in the case of what i experienced, there is no intervention that would have allowed me to rinse the rest of the blood back due to machine error.It is imperative that specific machine be replaced by a new machine in room prior to my patient receiving any more crrt.

• Brand Name: 2008 SERIES HEMODIALYSIS MACHINES
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.; 920 winter street; waltham MA 02451
• MDR Report Key: 10851554
• MDR Text Key: 216611571
• Report Number: 10851554
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/11/2020

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 Catalogue Number: 2008K2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA