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 2017-05-01 for CLINIMACS PLUS INSTRUMENT 151-01 manufactured by Miltenyi Biotec Gmbh.

Event Text Entries

[74278054] Pt is a (b)(6) male with a history of recurrent diffuse large b-cell lymphoma, he received a tcr-alpha/beta and cd19 depleted haploidentical stem cell transplant on (b)(6) 2016. On (b)(6) 2017, the pt presented with loss of appetite, weight loss, weakness and hypoxia, which led to admission. The pt had flow cytometry run on bal fluid on (b)(6) 2017 which showed no evidence for lymphoma. Bronchoscopy was performed on (b)(6) 2017 and infectious work-up as well as cytology and flow cytometry were negative. Then, on (b)(6) 2017, the pt had flow cytometry run on pleural fluid which was found to be consistent with relapsed diffuse large b-cell lymphoma. Once relapse of lymphoma was known, it did not feel there was any reasonable treatment that could be administered given the pt's age, functional status, and disease course, however, the pt was treated with high dose steroids which led to a brief acute improvement in hypoxia. The pt was then discharged from the hospital to hospice on (b)(6) 2017. We were notified on friday (b)(6) 2017 that the pt had passed away on sunday (b)(6) 2017. There is no autopsy being performed on this pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069461
• MDR Report Key: 6537135
• Date Received: 2017-05-01
• Date of Report: 2017-04-27
• Date of Event: 2017-04-16
• Date Added to Maude: 2017-05-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CLINIMACS PLUS INSTRUMENT
• Generic Name: MAGNETIC CELL SELECTION SYSTEM FOR CD34+CELLS
• Product Code: OVG
• Date Received: 2017-05-01
• Catalog Number: 151-01
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MILTENYI BIOTEC GMBH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2017-05-01