FDA Adverse Event Death Summary report: N

CLINIMACS PLUS INSTRUMENT

MDR report key: 6386791 · Received March 7, 2017

Report

Report Number: MW5068315
Event Type: Death
Date Received: March 7, 2017
Date of Event: February 26, 2017
Report Date: November 4, 2016
Manufacturer: MILTENYL BIOTEC GMBH
Product Code: OVG
Adverse Event: Yes
Report Source: Voluntary report
Reporter Location: WI, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

PATIENT IS A (B)(6) MALE WITH A HISTORY OF RECURRENT FOLLICULAR LYMPHOMA. HE WAS REGISTERED TO (B)(6) ON (B)(6) 2016. HE RECEIVED A TCR-ALPHA/BETA AND CD19 DEPLETED HAPLOIDENTICAL STEM CELL TRANSPLANT ON (B)(6) 2016. THE PATIENT HAD BEEN FOLLOWING UP WEEKLY POST TRANSPLANT WITH NO EVIDENCE OF GRAFT=VERSUS-HOST DISEASE AND HIS LYMPHOMA SHOWED IMPROVEMENT AT THE DAY +100 VISIT ON (B)(6) 2017. ON (B)(6) 2017 WE WERE INFORMED THAT THE PATIENT PASSED AWAY ON (B)(6) 2017. THE TREATING PHYSICIAN RECEIVED A CALL FROM THE MEDICAL EXAMINER. THE ONLY DETAILS REGARDING THE EVENT AVAILABLE AT THE TIME ARE THAT THE PATIENT REPORTED NOT FEELING WELL AND CALLED A FAMILY MEMBER TO TAKE HIM TO THE ED. HE LOST CONSCIOUSNESS AND THE FAMILY MEMBER PERFORMED CPR. WHEN THE PARAMEDICS ARRIVED THE PATIENT WAS PRONOUNCED DEAD AND WAS NOT TAKEN TO A HOSPITAL. THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. WE ARE AWAITING THE RESULTS OF AN AUTOPSY AND WILL PROVIDE A FOLLOW UP TO THIS REPORT WITH MORE DETAILS WHEN THEY ARE KNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
167284	CLINIMACS PLUS INSTRUMENT	CLINIMACS PLUS INSTRUMENT	OVG	MILTENYL BIOTEC GMBH	CLINIMACS PLUS INSTRUMENT

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Death	FLUCONAZOLE\| FUROSEMIDE\| LEVOTHYROXINE\| LISINOPRIL\| ONDANSETRON\| OTC MEDS: MULTIVITAMIN WITH MINERALS TAB\| OXYCODONE\| POSACONAZOLE\| PREDNISONE\| PROCHLORPERAZINE\| RANITIDINE\| RX MEDS: ACYCLOVIR\| TAMSULOSIN