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

Model Number UNKNOWN

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)

Patient Problems Cardiac Arrest (1762); Loss of consciousness (2418)

Event Date 04/03/2020

Event Type  Injury  

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 a dialysis session a patient had to be placed in intensive care with the diagnosis of high potassium level and high weight gain, because all the isolated ultra filtration (iso-uf) buttons in the treatment profile were inadvertently switch to "on" by the healthcare professional while setting the nipro surdial¿ x machine.Due to the accidental activation of all iso-uf buttons, the potassium level rose to a life threatening level and the patient was resuscitated because the patient was briefly unconscious with no pulse detectable.The patient was treated with 500 ml of nacl (sodium chloride) in the icu and once reanimated received a dialysis session of 5 hours by using another machine.No further information was provided.

• 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: 12276617
• MDR Text Key: 265059791
• Report Number: 3016250252-2021-00001
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization