MAUDE Adverse Event Report: SHIBUYA (SBY) SURDIAL X; HEMODIALYSIS MACHINE

Model Number SURDIAL-X2-HDF-UJ

Device Problem No Audible Alarm (1019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer evaluated the device in question and determined that the device is similar to 510k# k182940, therefore mdr reportability was detemined on july 8, 2021.

Event Description

During the reinfusion, after dialysis treatment, the nurse witnessed air passing the clamp box, through the vnous line without the machine giving any alarm or operating the venous clamp.There were no injuries or consequences to the patient.Inspection was carried out by nipro service technician.The tech checked the clamp box for damage, then checked its calibration.No adjustment necessary.Ran machine through a simulated treatment and activated the air bubble alarm with actual air bubbles many times and saw that the clamp box was operating correctly.During reinfusion, the tech allowed the venous chamber run empty and the venous clamp again clamped the line and the air bubble alarm came up.The machine is currently being used at the facility.

Manufacturer Narrative

The manufacturer evaluated the device in question and determined that the device is similar to 510k# k182940, therefore mdr reportability was detemined on july 8, 2021.

Event Description

During the reinfusion, after dialysis treatment, the nurse witnessed air passing the clamp box, through the vnous line without the machine giving any alarm or operating the venous clamp.There were no injuries or consequences to the patient.Inspection was carried out by nipro service technician.The tech checked the clamp box for damage, then checked its calibration.No adjustment necessary.Ran machine through a simulated treatment and activated the air bubble alarm with actual air bubbles many times and saw that the clamp box was operating correctly.During reinfusion, the tech allowed the venous chamber run empty and the venous clamp again clamped the line and the air bubble alarm came up.The machine is currently being used at the facility.

• Brand Name: SURDIAL X
• 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: 12287837
• MDR Text Key: 265391971
• Report Number: 3016250252-2021-00025
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K182940
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURDIAL-X2-HDF-UJ
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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