MAUDE Adverse Event Report: OUTSET MEDICAL INC. TABLO CARTRIDGE ARTERIAL END OF; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number PN-0004220-A

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Dizziness (2194); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/09/2024

Event Type  Injury  

Event Description

Pt c/o (patient complained of) light headedness and cramping near end of tx (treatment), fluids given and blood leak noticed from arterial end of dialyzer, blood on floor was about 200+ mls, stat hgb 6.9.Dr notified and 1 unit of rbc's (red blood cells) given.

• Brand Name: TABLO CARTRIDGE ARTERIAL END OF
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): OUTSET MEDICAL INC.; san jose CA 95134
• MDR Report Key: 18739917
• MDR Text Key: 335865085
• Report Number: MW5151774
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PN-0004220-A
• Device Catalogue Number: 250326
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American