MAUDE Adverse Event Report: LIVANOVA / CARDIAC ASSIST, INC. TANDEMHEART PUMP KIT; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 5120-00000

Device Problems No Audible Alarm (1019); Fluid/Blood Leak (1250); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/27/2021

Event Type  Injury  

Event Description

Bedside nurse was bathing the patient, and noticed blood on the sheets of the bed.No alarms were active, and the pump was performing as usual.Upon further inspection, blood was coming from the outflow portion of the device.The nurse notified the charge nurse, physician, and circulatory support.The tubing was put secured by circulatory support and reinforced with a zip tie band on the outflow portion of the device.Ongoing monitoring of patient continued with no further pump concerns.Manufacturer's clinical representative was called, and surveyed the incident.Approved the securing of the outflow portion with a tie band.The observed portion of tubing that was noted to be leaking is preinstalled by the manufacturer.This is the amended submission for the previous form (b)(4).Fda safety report id# (b)(4).

• Brand Name: TANDEMHEART PUMP KIT
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA / CARDIAC ASSIST, INC.; pittsburgh PA 15238
• MDR Report Key: 13257957
• MDR Text Key: 284004019
• Report Number: MW5106665
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5120-00000
• Device Catalogue Number: 5120-00000
• Was Device Available for Evaluation?: Yes
• 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: 44 YR
• Patient Sex: Female
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American