MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) HEMODIALYSIS SYSTEM; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Device Problems Inaccurate Flow Rate (1249); Obstruction of Flow (2423); Protective Measures Problem (3015)

Patient Problems Low Blood Pressure/ Hypotension (1914); Ventilator Dependent (2395); Confusion/ Disorientation (2553)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

3 tablo pump failures leading to delay of care.Adult morbidly obese female pt admitted with acute kidney injury requiring emergent dialysis.Pt alert, confused, requiring bilevel positive airway pressure; hypotensive requiring levophed continuous medication drip, dialysis catheter in right internal jugular.On initial start of continuous renal replacement therapy (crrt) the tablo machine displayed alarm "bypass valve failure", outset medical notified, taken out of service, case # assigned.With second tablo machine, first alarm displayed "high vascular pressure", multiple attempts at troubleshooting line including flushing line, switching blue/red lines, repositioning pt.Vascath was found to be clotted and required instillation of heparin and heparin continuous drip to be started, treatment paused for approximately 3 hours waiting for labs and heparin to be dosed to by pharmacy.Second alarm from same tablo machine displayed "water module failure".Machine removed from pt room, outset notified, able to troubleshoot over the phone and resolve problem, third tablo machine displayed alarm of "incorrect blood pump rate"" outset medical notified, instructed to take machine out of service, case # assigned.4th tablo machine brought to bedside and was able to initiate treatment, total of 6 cartridge/filter changes occurred.Pt received approximately 1.5 hours of crrt throughout the 12-hour shift.Potassium remained critically high, with minimal urine output throughout night.Recommend having these issues resolved sooner rather than later as it is delaying care for critically ill patients.These errors are not being able to be troubleshooted by the bedside rn.How, if possible, can we prevent/limit these troubleshooting alarms from recurring so often?".

Event Description

No equipment issues or human factors interacting with equipment identified.

• Brand Name: TABLO(R) HEMODIALYSIS SYSTEM
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• MDR Report Key: 14013730
• MDR Text Key: 288604717
• Report Number: 14013730
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2022
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 17885 DA
• Patient Sex: Female
• Patient Weight: 326 KG
• Patient Race: White