FDA Adverse Event
Death
Summary report: N
SURDIAL X
MDR report key: 12277856
·
Received August 4, 2021
Report
- Report Number
- 3016250252-2021-00002
- Event Type
- Death
- Date Received
- August 4, 2021
- Date of Event
- June 12, 2020
- Report Date
- August 4, 2021
- Manufacturer
- SHIBUYA (SBY)
- Product Code
- KDI
- PMA / PMN Number
- K182940
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER EVALUATED THE DEVICE IN QUESTION AND DETERMINED THAT THE DEVICE IS SIMILAR TO 510K# K182940, THEREFORE MDR REPORTABILITY WAS DETERMINED ON (B)(6) 2021.
Description of Event or Problem · 1
CUSTOMER STATED THAT THE PATIENT WAS CONNECTED VIA CENTRAL VENOUS CATHETER TO THE DIALYSIS MACHINE. AFTER APPROXIMATELY 10 MINUTES OF DIALYSIS TREATMENT, THE MACHINE WAS ALARMING WITH LOW ARTERIAL PRESSURE. BLOOD PUMP WAS STOPPED, AND LINES WERE REVERSED TO IMPROVE ARTERIAL PRESSURES AND BLOOD FLOW. WITHIN 2 MINUTES THE PATIENT'S CONDITION DETERIORATED AND, ON EXAMINATION, IT BECAME EVIDENT THAT A VENOUS LINE DISCONNECTION HAD OCCURRED. FLUID RESUSCITATION WAS ATTEMPTED BUT THE PATIENT PASSED AWAY. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1173360 | SURDIAL X | HEMODIALYSIS MACHINE | KDI | SHIBUYA (SBY) | SURDIAL-X2-HFDP-UJ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |