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U.S. Department of Health and Human Services

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

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SHIBUYA (SBY) SURDIAL X HEMODIALYSIS MACHINE Back to Search Results
Model Number UNKNOWN
Device Problems Use of Incorrect Control 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.
 
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Brand NameSURDIAL X
Type of DeviceHEMODIALYSIS 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 Key12276617
MDR Text Key265059791
Report Number3016250252-2021-00001
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K182940
Number of Events Reported1
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 Received08/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/04/2020
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 Treatment Data
Date Received: 08/04/2021 Patient Sequence Number: 1
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