MAUDE Adverse Event Report: OUTSET MEDICAL, INC. TABLO(R) CARTRIDGE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number PN-0004220

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/19/2024

Event Type  malfunction  

Event Description

Technicians noted blood had dripped out of the bottom of the dialysis cartridge, down the front of the dialysis machine and onto the floor.The nurse that reported it to the supervisor, stated the total estimated blood loss was 20cc.The cartridge was saved.The cartridge was inspected and it was found that the connection to the loop of tubing that goes around the blood pump had leaked and dripped onto the lower connection, then out the bottom of the cartridge.Pictures were taken of the back of the cartridge, along with the bag with the lot number, and sent in an email to our outset representative, as well as the dialysis manager, the biomedical engineering manager.The day this happened, the rn notified the provider, and was instructed to monitor the patient for fevers, and to draw blood cultures if any developed.The patient has not developed any fevers, and his hemoglobin was not affected.The patient was on tablo machine #: (b)(6).The tablo cartridge lot number was m23137l02s01, expiration date 11/30/2024.

• Brand Name: TABLO(R) CARTRIDGE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL, INC.; 3052 orchard drive; san jose CA 95134
• MDR Report Key: 18929497
• MDR Text Key: 337992511
• Report Number: 18929497
• Device Sequence Number: 1
• Product Code: FJK
• 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
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PN-0004220
• Device Lot Number: M23137L02S01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/01/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male