MAUDE Adverse Event Report: CARDIACASSIST, INC. TANDEMHEART ARTERIAL CANNULA

Model Number 5130-1717

Device Problems Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problems Cardiomyopathy (1764); Congestive Heart Failure (1783); Left Ventricular Failure (1948)

Event Date 03/12/2014

Event Type  Death  

Event Description

On (b)(6) 2014, (b)(6) reported a case where a patient expired secondary to the cannula being forceably removed and exsanguination.I wanted to let you know one of the pts on tandem at (b)(6) decannulated himself today and rapidly exsanguinated.At this point there are more questions than answers, but here are the facts as i know them.The pt was stable on support, awake, alert, oriented.He was aware he was not permitted to bend his leg or get out of bed.He stood up and got out of bed (some speculation to use the bed pan/ bathroom).When the nurse went into the room he was face down on the floor with no evidence of bleeding.Then he repeatedly attempted to get back on his feet.He was a large strong man.During this struggle he may have forcefully pulled on the sutured outflow cannula with his knee or leg removing the sutured protek cannula.The immediate steps taken at that point are unknown to me.No other details were currently available as the staff involved were being debriefed with internal hospital leadership at the time.Th placed without incident.Above initial information was clarified with site on (b)(6) 2014, further clarification from site revealed the following: between 0900 and 1000 on (b)(6) 2014 for unknown reasons, the pt rolled himself from the supine position in his bed, and landed in the prone position on the floor.The controller (b)(4) was positioned on the opposite side of the bed.The pts nurse was reportedly in the pts room at the doorway at this time.She immediately called for help.The pt was making attempts to stand by getting on his hands and knees.By the time the staff was able to roll the pt onto his back the arterial cannula had been dislodged and the pt lost a significant amount of blood.The immediate action taken by the staff at that time remains unclear.Resuscitation efforts were unsuccessful.Prior to this event the pt was awake, alert, and oriented.The pt also used the bed pan a short time prior to this event and knew the importance of keeping his leg straight.He was reportedly approximately 250-275 lbs and over 6 feet tall.

• Brand Name: TANDEMHEART ARTERIAL CANNULA
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): CARDIACASSIST, INC.; pittsburgh PA
• Manufacturer Contact: kevin posey ; 240 alpha dr.; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 3763473
• MDR Text Key: 4488061
• Report Number: 2531527-2014-00005
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K120543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: 5130-1717
• Device Catalogue Number: 5130-1717
• Device Lot Number: AM017457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2014
• Initial Date FDA Received: 04/07/2014
• 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
• Treatment: IABP
• Patient Outcome(s): Death
• Patient Age: 53 YR
• Patient Weight: 125