MAUDE Adverse Event Report: CARDIAC ASSIST, INC. TANDEMHEART TRANSSEPTAL CANNULA - EF; CANNULA, VASCULAR, CARDIOPUL BYPASS

Model Number 5140-6221

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Left Ventricular Failure (1948); Cardiogenic Shock (2262)

Event Date 01/31/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, (b)(6) of the (b)(6) clinic support staff was informed of a transseptal cannula that was dislocated due to movement/manipulation of the pt to clean her after a loose bowel movement that soiled her all over.The nurse and the attending physician were present at the time of the cleaning.The dislodgement occurred when the pt was returned to a supine position.The nurse and physician notice the 'color of the blood' and the pt was sent immediately to the cath lab.A 72cm transseptal cannula was placed from the lfv.The pt remained stable.Pt was transitioned to heartmate ii and explanted from the tandemheart on (b)(6) 2014 with no residual negative effects.

• Brand Name: TANDEMHEART TRANSSEPTAL CANNULA - EF
• Type of Device: CANNULA, VASCULAR, CARDIOPUL BYPASS
• Manufacturer (Section D): CARDIAC ASSIST, INC.; pittsburgh PA
• Manufacturer Contact: kevin posey ; 240 alpha dr.; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 3650176
• MDR Text Key: 18569136
• Report Number: 2531527-2014-00002
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K052570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2014

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 Model Number: 5140-6221
• Device Catalogue Number: 5140-6221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2014
• Initial Date FDA Received: 02/17/2014
• 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
• Patient Outcome(s): Required Intervention