MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for TABLO HEMODIALYSIS SYSTEM PN-0003000 manufactured by Outset Medical, Inc..
[184854640]
Lead technical support specialist reviewed the system log and all associated parameters and determined that the tablo system was functioning as designed. Field service engineer (fse) verified the console is operating as intended after the event. Event is believed to be related to pre-existing patient conditions. A review of production records for this unit did not note any manufacturing nonconformances that would contribute to a product event.
Patient Sequence No: 1, Text Type: N, H10
[184854641]
It was reported that patient passed away during dialysis treatment. Prior to treatment, the patient was in critical condition. Patient was rushed to intensive care unit (icu) and intubated with an emergency dialysis treatment ordered. Patient was diaphoretic and vital signs were critical. Death is believed to be related to patient's pre-existing conditions and not due to the tablo device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010355846-2020-00015 |
| MDR Report Key | 9878061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-03-02 |
| Date Facility Aware | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2018-12-27 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Phone | 6692318235 |
| Manufacturer G1 | OUTSET MEDICAL, INC. |
| Manufacturer Street | 1830 BERING DRIVE |
| Manufacturer City | SAN JOSE CA 951124212 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 951124212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TABLO HEMODIALYSIS SYSTEM |
| Generic Name | DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM |
| Product Code | KDI |
| Date Received | 2020-03-25 |
| Model Number | PN-0003000 |
| Catalog Number | PN-0003000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OUTSET MEDICAL, INC. |
| Manufacturer Address | 1830 BERING DRIVE SAN JOSE CA 951124212 US 951124212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-25 |