MAUDE Adverse Event Report: THORATEC LVAD

Model Number 102952

Device Problem Detachment Of Device Component (1104)

Patient Problem Exsanguination (1841)

Event Date 08/04/2015

Event Type  Death  

Event Description

Report to dept of health: this is a (b)(6) male who initially presented with chest pain.Upon eval, a code stemi was initiated and the pt went to the cath lab.During the procedure, cardiogenic shock was suspected and an iabp was placed.He was evaluated by the transplant team on (b)(6) 2015.On (b)(6) 2015, a biventricular centrimag support was required during this bridge period for transplant.On (b)(6) 2015, the pt's transplant workup had been completed and he was listed as a status 1a for heart/kidney transplant.On (b)(6) 2015, his transplant status was changed to status 7 due to medical instability.On (b)(6) 2015 at 2:40am, the pt was noted by the rn to be sitting on the edge of the bed with his legs dangling.At 2:45, the pt started to lie back on the bed and the rn assisted him in lifting his legs up.At this point, the pt noticed blood gushing from the drive lines of the centrimag.The lvad cannula from the lv to the lvad (centrimag) had come apart at the (mfr sealed) first banding.This rendered the tube incapable of staying in place.This caused fatal exsanguination.This is believed to be a complete product malfunction.The fda and mfr are being notified.The tubing was evaluated after the event and the first banding that is sealed by the mfr had come off.This case was accepted by the (b)(6).Immediate clinical action(s) taken for pt: the rn was present for the event and she immediately applied manual pressure and called for help.Multiple rns and physicians came to the bedside to assist.Massive exsanguination occurred and a code blue was called and all resuscitative measures were done including intubation, but they were unsuccessful.The pt was pronounced at 3:15am.

• Brand Name: LVAD
• Type of Device: LVAD
• Manufacturer (Section D): THORATEC
• MDR Report Key: 5034223
• MDR Text Key: 24209649
• Report Number: MW5055754
• Device Sequence Number: 1
• Product Code: DSQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 102952
• Device Lot Number: 103511-LA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 52 YR