MAUDE Adverse Event Report: MILTENYI BIOTEC GMBH CLINIMACS PLUS INSTRUMENTS; MAGNETIC CELL SELECTION SYSTEM FOR CD 34+ CELLS

Catalog Number 151-01

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Death (1802); Dyspnea (1816); Foreign Body Reaction (1868); Renal Failure (2041)

Event Date 06/17/2019

Event Type  Death  

Event Description

Pt is a (b)(6) y/o male with history of recurrent stage iv peripheral t-cell lymphoma.He received a tcr-alpha / beta and cd19 depleted haploidentical stem cell transplant on (b)(6) 2018.Briefly, he has been admitted five times since his bone marrow transplant for a number of cardiac issues, graft-versus- host disease, multiple infections and renal failure.Most recently this pt was admitted on (b)(6) 2019 for worsening dyspnea on exertion and found to be bacteremic.The pt was intubated on (b)(6) 2019 due to persistent hypoxia on cpap.The etiology of this was felt to be multifactorial, and likely largely related to previously known decompensated heart failure.Repeat echocardiograms during this hospitalization did not reveal significant changes in ejection fraction.The pt received continuous renal replacement therapy starting (b)(6).The pt's respiratory status had improved enough to be extubated on friday evening, (b)(6) 2019.He developed worsening abdominal pain on (b)(6), requiring increased pressor support and was thus sent for stat ct angio chest / abdominal / pelvis that suggested extensive intestinal ischemia, thought to be more due to hypoperfusion rather than distal emboli.Wbc count rose and thus infection was suspected.Due to poor prognosis, pt was transitioned to comfort measures and passed on (b)(6) 2019.Autopsy was discussed and not desired.

• Brand Name: CLINIMACS PLUS INSTRUMENTS
• Type of Device: MAGNETIC CELL SELECTION SYSTEM FOR CD 34+ CELLS
• Manufacturer (Section D): MILTENYI BIOTEC GMBH
• MDR Report Key: 8811392
• MDR Text Key: 151857466
• Report Number: MW5088260
• Device Sequence Number: 1
• Product Code: OVG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 151-01
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 57 YR
• Patient Weight: 74