CLINIMACS CLINIMACS PLUS INSTRUMENT 171-01/70025/16201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-22 for CLINIMACS CLINIMACS PLUS INSTRUMENT 171-01/70025/16201 manufactured by Miltenyi Biotec.

Event Text Entries

[4922852] (b)(6) is a (b)(6) boy who was diagnosed as having severe combine immune deficiency on newborn screening. He underwent an unrelated bone marrow transplant on (b)(6) 2014. His course has been complicated by toxicity and infection. He was admitted to the picu on three separate occasions; firstly on (b)(6) 2014 for fluid overload and was transferred back to the bmtu on (b)(6) 2014; secondly on (b)(6) 2014 for severe vod and returned to bmtu on (b)(6) 2014; and lastly on (b)(6) 2014 and stayed until the time of his death. His infectious complications were: disseminated cmv pre and post transplant; disseminated ebv post-transplant; pulmonary aspergillosis; pjp pneumonia (based on clinical symptoms); presumed sepsis culture negative (abdominal pain, tachycardia, hypotension). His toxicities were respiratory failure; severe vod; pulmonary hemorrhage; osteopenia with multiple small bone fractures; pancreatitis; renal insufficiency requiring peritoneal dialysis; ards; hypertriglyceridemia. All medically appropriate intensive care was provided in order to sustain him. However, it had become more difficult to maintain his oxygenation despite the use of oscillator ventilator and nitric oxide. On (b)(6) 2014 he was made and (allowed natural death) by his parents and the picu attending at 0200 and he succumbed at 0955.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5038339
MDR Report Key4119133
Date Received2014-09-22
Date of Report2014-09-22
Date of Event2014-09-19
Date Added to Maude2014-09-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCLINIMACS
Generic NameCLINIMACS SYSTEM
Product CodeKSR
Date Received2014-09-22
Model NumberCLINIMACS PLUS INSTRUMENT
Catalog Number171-01/70025/16201
Lot Number6131007010/D0481/B2010
Device Expiration Date2015-08-01
OperatorHEALTH PROFESSIONAL
Device Sequence No1
Device Event Key0
ManufacturerMILTENYI BIOTEC
Manufacturer AddressBERGISCH GLADBACH D51429 D51429


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2014-09-22

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