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

Model Number 5120-00000

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/27/2021

Event Type  Injury  

Event Description

Statement from bedside nurse; i (bedside nurse) had been bathing my patient and noticed blood at the bottom of the bed.No alarms had gone off, the tandem pump was functioning normal.Upon further inspection of the area, it appeared that blood was coming out of the tandem pump at the outflow site.I got my charge nurse who has 25+ years experience to look at this tandem with me.I pushed the tubing together to better secure it and stop the bleeding.Notified the physician and circ support came to the bedside as well.They put secure tags on the tubing.The charge and saw my push the tubing back in place.An xray was done after to ensure proper placement of tandem.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: 13205793
• MDR Text Key: 283594188
• Report Number: MW5106527
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• 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?: No
• 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