MAUDE Adverse Event Report: SHIBUYA (SBY) NIPRO SURDIAL DX HEMODIALYSIS SYSTEM; HEMODIALYSIS MACHINE

Catalog Number SURDIAL X

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Detachment of Device or Device Component (2907)

Patient Problem Burn(s) (1757)

Event Date 06/24/2021

Event Type  Injury  

Event Description

We have been informed about an incident where a nurse had contact with hot water while cleaning the hemodialysis machine.The machine was put into hot disinfection and the nurse continued cleaning / disinfecting the surface of the machine.While she was doing this, suddenly the silicone tube from the b-nozzle (bicarb nozzle) on the bsp panel (blood pump / syringe pump panel) side "popped-off" and hot water was spilled over her leg.She was suffering and showing signs of scalding.No additional information has been received at this time.

Manufacturer Narrative

Additinoal information received from the user: the nurse was checked by a physician.She received medical treatment/coverage with wound gauze to support the healing on the leg.The nurse is currently recovered with minor marks remaining on the skin.Section 5 of the manufacturer report attached has the following warnings which are already included in the machine's instruction manual and are continually reminded in the instruction manual.6.3.Check during cleaning operation.Warning: the surfaces of exterior parts and silicone tubes become hot during the hot rinse and hot disinfection operations.Handle with care not to get burn injury.The inside of the dialysate circuit becomes very hot during the hot rinse and hot disinfection operations.Do not operate with uncovered machine.Temperatures of solution may rise to nearly 100°c during the hot rinse and hot disinfection operations.Do not touch spills when leakage is found.You may get burned.

Event Description

We have been informed about an incident where a nurse had contact with hot water while cleaning the hemodialysis machine.The machine was put into hot disinfection and the nurse continued cleaning / disinfecting the surface of the machine.While she was doing this, suddenly the silicone tube from the b-nozzle (bicarb nozzle) on the bsp panel (blood pump / syringe pump panel) side "popped-off" and hot water was spilled over her leg.She was suffering and showing signs of scalding.No additional information has been received at this time.

• Brand Name: NIPRO SURDIAL DX HEMODIALYSIS SYSTEM
• Type of Device: HEMODIALYSIS MACHINE
• Manufacturer (Section D): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• Manufacturer (Section G): SHIBUYA (SBY); 2-72, wakamiya; kanazawa, isikawa 920-0 054; JA 920-0054
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 12609373
• MDR Text Key: 275895858
• Report Number: 3016250252-2021-00027
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: SURDIAL X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other