FDA Adverse Event Injury Summary report: N

CLINIMACS PLUS INSTRUMENT

MDR report key: 6030470 · Received October 13, 2016

Report

Report Number
MW5065401
Event Type
Injury
Date Received
October 13, 2016
Date of Event
September 27, 2016
Manufacturer
MILTENYI 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

PT IS A (B)(6) Y/O MALE WITH HISTORY OF RECURRENT HODGKIN LYMPHOMA. HE RECEIVED A TCR-ALPHA/BETA AND CD19 DEPLETED HAPLOIDENTICAL STEM CELL TRANSPLANT ON (B)(6) 2016. THE PT WAS SEEN IN CLINIC FOR ROUTINE F/U AND HAD BEEN EXPERIENCING CHEST DISCOMFORT WITH DEEP BREATHS AND WORSENING COUGH. THE PT WAS ADMITTED TO THE INPATIENT UNIT ON OXYGEN. ECHOCARDIOGRAM SHOWED PERICARDIAL EFFUSION, WITH CONCERN FOR TAMPONADE. CHEST CT SHOWED WORSENING UPPER LOBE PREDOMINANT GROUND GLASS OPACITIES. CARDIOLOGY DID NOT FEEL PERICARDIOCENTESIS WAS NEEDED EMERGENTLY, BUT, PERFORMED IT NEXT MORNING AND DRAIN PLACED. THE FOLLOWING DAY ((B)(6) 2016), THERE WAS REACCUMULATION OF THE EFFUSION, SUSPECTED TO BE A BLOCKAGE WHICH WAS RESOLVED WITH FLUSHING. ECHO ON ( (B)(6) 2016 SHOWED TRIVIAL EFFUSION. CARDIAC MRI ON (B)(6) 2016 SHOWED CONSTRICTIVE PERICARDITIS. DRAIN WAS REMOVED ON (B)(6) 2016. REPEAT ECHO ON (B)(6) 2016 SHOWED NO PERICARDIAL EFFUSION. CARDIOLOGY RECOMMENDED REPEAT ECHO IN 2 WEEKS. THE PT WAS DISCHARGED AND IS SO FAR CLINICALLY STABLE AS AN OUTPATIENT. WE ARE REPORTING THIS EVENT BECAUSE IT WAS A SERIOUS ADVERSE EVENT THAT IS RELATIVELY UNEXPECTED WITH THE TRANSPLANT REGIMEN. WE SUSPECT THAT THE REASON FOR THIS COMPLICATION MIGHT BE A COMBINATION OF HIS PRIOR AND RECENT CHEMO/RADIATION. WE DO NOT FEEL THE DEVICE (CLINIMACS COLUMN) TO BE RELATED AT ALL. HOWEVER, GIVEN THE FACT THAT THE IDE ENCOMPASSED THE ENTIRE CONDITIONING REGIMEN, WE ARE STILL REPORTING THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
677510 CLINIMACS PLUS INSTRUMENT CLINIMACS PLUS INSTRUMENT OVG MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Patients

Seq Age Sex Outcome Treatment
1 29 YR Hospitalization ACETAMINOPHEN| ACYCLOVIR| ALBUTEROL| AMBIEN| AUTOLOGOUS STEM CELL| AZITHROMYCIN| BACTRIM| BRENTUXIMAB| BUDESONIDE-FORMOTEROL| CARBOPLATIN| CARVEDILOL| COLCHICINE| COMPAZINE| ETOPOSIDE CHEMOTHERAPY| FLUCONAZOLE| FUROSEMIDE| IBUPROFEN| IFOSFAMIDE| LEVOTHYROXINE| LIDOCAINE-PRILOCAINE| LISINOPRIL| LOPERAMIDE| MONTELUKAST| NIVOLUMAB| OXYBUTYNIN| OXYCODONE| PREDNISONE| RADITION| RANITIDINE| SIROLIMUS