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

Model Number 191124

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 06/25/2019

Event Type  malfunction  

Event Description

The patient was in the dialysis unit for routine dialysis.The nurse moved the dialysis machine closure to where the patient was seated to provide some slack on the venous line that appeared to be pulling on the patient.As the machine was slid the left front wheel caster fell off.The dialysis machine began to fall toward the nurse and the patient.The nurse caught the machine and a second nurse replaced the wheel into the machine.The patient was still on treatment.There was no harm to the patient.

• Brand Name: 2008T BLUESTAR HEMODIALYSIS MACHINE
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): FRESENIUS USA, INC.; 920 winter street; waltham MA 02451 1457
• MDR Report Key: 8939822
• MDR Text Key: 155817606
• Report Number: 8939822
• 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: 06/28/2019,06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 191124
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/28/2019
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4745 DA
• Patient Weight: 36