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

Device Problems Application Program Problem (2880); No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/06/2022

Event Type  malfunction  

Event Description

The patient's arterial catheter was clamped per instructions.The tablo computer alarmed saying the patient line was not clamped.I ensured the clamp was closed.I then attempted to continue.The same alarm was sounded.I then manually held down the clamp tightly.The tablo attempted to send the blood back to the patient, but the blood was not being pulled or pushed through the line, thus not returning to the patient, despite the computer "showing" it was being returned.I attempted to manually return the blood.The tablo then sounded an alarm and force shut down.When the tablo turned back on, it showed a complete cycle.Due to time and inability to get the blood manually returned i notified the provider the blood in the line was not returned to the patient.He instructed to draw morning labs and check hemoglobin.Vitals were stable.Hemoglobin (hgb) did have a drop from 7.5 to 6.8.The provider ordered 1 unit of blood to be given." nurse had this issue two times.The first she called rn and they discovered the nurse had the wrong clamp clamped.The nurse was educated and instructed to use the clamp on the patient catheter.The next run the nurse clamped the correct clamp but the machine gave the same alarm.The machine was acting like the blood was being returned to the patient but in fact, was not.They tried to manually give back blood but eventually the machine forced a shut down and the blood was wasted.Due to the hgb drop, blood products were needed.Tablo machine was taken out of service to be looked at.There is no associated service report from tablo for reference.

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: 14013725
• MDR Text Key: 288603424
• Report Number: 14013725
• 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 Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: Black Or African American