FDA Adverse Event Death Summary report: N

ABBOTT

MDR report key: 7165228 · Received December 28, 2017

Report

Report Number
7165228
Event Type
Death
Date Received
December 28, 2017
Date of Event
December 19, 2017
Report Date
December 21, 2017
Product Code
DSQ
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
SC, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

PATIENT WAS A NEW HM2 IMPLANT DONE ON (B)(6) 2017. PATIENT HAD A HISTORY OF CHRONIC SYSTOLIC HEART FAILURE AND HAD AN AORTIC PLUGGING, TRICUSPID VALVE REPAIR AND PACEMAKER REVISION ALONG WITH THE LVAD IMPLANT. HE WAS LEFT OPEN AND TAKEN BACK TO THE OPERATING ROOM FOR A WASHOUT ON (B)(6) 2017. HIS SKIN WAS LEFT OPEN FOR A DELAYED CLOSURE WITH WOUND VAC. HE HAD A VERY DIFFICULT POST OP RESULTING IN NUMEROUS COMPLICATIONS. PATIENT DEVELOPED KLEBSIELLA PNEUMONIA AND WAS TREATED WITH IV ANTIBIOTICS AND FOLLOWED CLOSELY BY ID. PATIENT WAS UNABLE TO BE TAKEN OFF THE VENTILATOR AND WAS TAKEN BACK TO THE OPERATING ROOM FOR A TRACHEOSTOMY ON (B)(6) 2017. HE WAS EVENTUALLY WEANED AND ABLE TO BE ON TRACH COLLAR. ON (B)(6) 2017, HE WAS TAKEN BACK TO THE OPERATING ROOM AGAIN FOR A OMENTAL STERNAL FLAP AND G TUBE PLACEMENT. THROUGHOUT HIS TIME IN THE HOSPITAL HE HAD SEVERAL POSITIVE BLOOD CULTURES AND WAS TREATED WITH IV ANTIBIOTICS FOR LEUKOCYTOSIS AND FEVER. BEGINNING AROUND (B)(6) 2017 HIS LDH BEGAN TO TREND UPWARDS AND HE EVENTUALLY PRESENTED WITH TEA COLORED URINE. OVER THE COURSE OF A WEEK IN MID (B)(6), HE BEGAN TO DECLINE AND PRESENTED WITH VOMITING SPELLS, ASPIRATION AND HYPOXIA. ON (B)(6) 2017, HE DECLINED IN HIS RESPIRATORY STATUS AND HAD TO BE PUT BACK ON THE VENTILATOR. INOTROPES WERE ADDED TO MANAGE BP. HE BECAME OBTUNDED AND NO LONGER RESPONSIVE. HIS WIFE DECIDED TO TRANSITION HIM TO HOSPICE CARE AND HE WAS MADE AN "ALLOW NATURAL DEATH" CODE STATUS. THE TEAM WAITED UNTIL ALL FAMILY COULD BE PRESENT, AND PER FAMILY'S WISHES, CARE WAS WITHDRAWN. THE VENTILATOR WAS TURNED OFF AND SWITCHED TO O2, THE LVAD WAS TURNED OFF AND THE PACEMAKER WAS DEACTIVATED. PATIENT EXPIRED AT 1534 ON (B)(6) 2017.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
932773 ABBOTT HEARTMATE II DSQ

Patients

Seq Age Sex Outcome Treatment
1 60 YR Death| H