MAUDE Adverse Event Report: CARDIAC ASSIST, INC. TANDEMHEART PUMP; NON-ROLLER HEARING BYPASS PUMP

Model Number 5120-0000

Device Problems Device Stops Intermittently (1599); Device Inoperable (1663)

Patient Problems High Blood Pressure/ Hypertension (1908); Left Ventricular Failure (1948); Multiple Organ Failure (3261)

Event Date 09/15/2012

Event Type  malfunction  

Event Description

This event is being submitted as a correction for this event in response to a 483 observation from (b)(4) 2014 for fei number (b)(4).On (b)(6) 2012, mr.(b)(6) of the (b)(6) support staff was notified that a tandemheart pump had failed and stopped turning after 10 days of use.Attempts to restart the pump were unsuccessful with the connected controller, as well as a back-up controller.A new pump was cut into the circuit and worked just fine with the back-up controller.The first controller was noted to be in a system failure mode when powered up, possibly due to the pump stoppage.

• Brand Name: TANDEMHEART PUMP
• Type of Device: NON-ROLLER HEARING BYPASS PUMP
• Manufacturer (Section D): CARDIAC ASSIST, INC.; pittsburgh PA
• Manufacturer Contact: kevin posey ; 240 alpha dr.; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 3754220
• MDR Text Key: 4552511
• Report Number: 2531527-2012-00006
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5120-0000
• Device Catalogue Number: 5120-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR