CLINIMACS PLUS INSTRUMENT #151-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for CLINIMACS PLUS INSTRUMENT #151-01 manufactured by Miltenyi Biotec Gmbh.

Event Text Entries

[73024218] Patient is a (b)(6) male with a history of recurrent mantle cell lymphoma. He received a tcr - alpha/beta and cd19 depleted haploidentical stem cell transplant on (b)(6) 2017. On (b)(6) 2017 he presented to clinic with elevated lfts, diarrhea, and rash on his upper neck, back and upper mid chest. He was admitted for evaluation of his liver and gi symptoms. A liver biopsy and skin biopsy performed on (b)(6) 2017 were both positive for graft-versus-host disease. The patient was started on tacrolimus and budesonide and steroids were increased. On (b)(6) 2017 tpn was started due to limited oral intake. On (b)(6) 2017 the patient was transferred to the critical care unit for worsening hypotension concerning for sepsis and was started on cefepime and flagyl. Blood cultures were positive for pan-sensitive streptococcus vestibularis. Daptomycin was added to the antibiotic regimen. On (b)(6) 2017 the patient went in atrial fibrillation and received metoprolol and diltiazem with no improvement before being started on amiodarone gtt. On (b)(6) 2017 enbrel was added for gvhd, but was discontinued after 2 doses as it was determined the patient was not responding. The patient's mental status seemed to be deteriorating for unclear reasons. Work-up included a lumbar puncture. Csf did not show evidence of lymphoma, however, infectious work-up showed hhv-6 pcr to be positive in the csf. On (b)(6) 2017 it was determined that the patient's status was declining and the acute gvhd was not improving despite critical care measures. The patient's family decided to begin comfort care measures. The patient was transferred to hospice care on (b)(6) 2017 and passed away on (b)(6) 2017 with acute graft - versus - host disease being the cause of death.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5069100
MDR Report Key6497048
Date Received2017-04-12
Date of Report2017-04-07
Date of Event2017-03-29
Date Added to Maude2017-04-17
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 FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCLINIMACS PLUS INSTRUMENT
Generic NameCLINIMACS PLUS INSTRUMENT
Product CodeOVG
Date Received2017-04-12
Model NumberCLINIMACS PLUS INSTRUMENT
Catalog Number#151-01
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMILTENYI BIOTEC GMBH


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2017-04-12

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