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 2016-10-13 for CLINIMACS PLUS INSTRUMENT 151-01 manufactured by Miltenyi Biotec Gmbh.

Event Text Entries

[57680642] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5065401
MDR Report Key6030470
Date Received2016-10-13
Date of Event2016-09-27
Date Added to Maude2016-10-14
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 Received2016-10-13
Model NumberCLINIMACS PLUS INSTRUMENT
Catalog Number151-01
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMILTENYI BIOTEC GMBH


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2016-10-13

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