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 2017-03-07 for CLINIMACS PLUS INSTRUMENT #151-01 manufactured by Miltenyl Biotec Gmbh.

Event Text Entries

[69481019] Patient is a (b)(6) male with a history of recurrent follicular lymphoma. He was registered to (b)(6) on (b)(6) 2016. He received a tcr-alpha/beta and cd19 depleted haploidentical stem cell transplant on (b)(6) 2016. The patient had been following up weekly post transplant with no evidence of graft=versus-host disease and his lymphoma showed improvement at the day +100 visit on (b)(6) 2017. On (b)(6) 2017 we were informed that the patient passed away on (b)(6) 2017. The treating physician received a call from the medical examiner. The only details regarding the event available at the time are that the patient reported not feeling well and called a family member to take him to the ed. He lost consciousness and the family member performed cpr. When the paramedics arrived the patient was pronounced dead and was not taken to a hospital. The cause of death is unknown at this time. We are awaiting the results of an autopsy and will provide a follow up to this report with more details when they are known.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5068315
• MDR Report Key: 6386791
• Date Received: 2017-03-07
• Date of Report: 2016-11-04
• Date of Event: 2017-02-26
• Date Added to Maude: 2017-03-08
• 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: CLINIMACS PLUS INSTRUMENT
• Product Code: OVG
• Date Received: 2017-03-07
• Model Number: CLINIMACS PLUS INSTRUMENT
• Catalog Number: #151-01
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MILTENYL BIOTEC GMBH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2017-03-07