MAUDE Adverse Event Report: NIKKISO MEDICAL SYSTEMS GMBH DBB-06 HEMODIALYSIS DELIVERY SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Lot Number 70018-03

Device Problem Insufficient Information (3190)

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

The nurse reported that during therapy with dbb06 nikkiso machine and serial (b)(6), a 73 years old patient presented a convulsion episode, machine is available for evaluation.Patient injury reported: yes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DBB-06 HEMODIALYSIS DELIVERY SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): NIKKISO MEDICAL SYSTEMS GMBH
• MDR Report Key: 17534140
• MDR Text Key: 321157093
• Report Number: MW5141043
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2011

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?: No
• Device Lot Number: 70018-03
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 73 YR