MAUDE Adverse Event Report: MILTENYL BIOTEC GMBH CLINIMACS PLUS INSTRUMENT

Model Number CLINIMACS PLUS INSTRUMENT

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

Patient Problems Death (1802); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 02/26/2017

Event Type  Death  

Event Description

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.

• Brand Name: CLINIMACS PLUS INSTRUMENT
• Type of Device: CLINIMACS PLUS INSTRUMENT
• Manufacturer (Section D): MILTENYL BIOTEC GMBH
• MDR Report Key: 6386791
• MDR Text Key: 69481019
• Report Number: MW5068315
• Device Sequence Number: 1
• Product Code: OVG
• 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: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CLINIMACS PLUS INSTRUMENT
• Device Catalogue Number: #151-01
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: FLUCONAZOLE; FUROSEMIDE; LEVOTHYROXINE; LISINOPRIL; ONDANSETRON; OTC MEDS: MULTIVITAMIN WITH MINERALS TAB; OXYCODONE; POSACONAZOLE; PREDNISONE; PROCHLORPERAZINE; RANITIDINE; RX MEDS: ACYCLOVIR; TAMSULOSIN
• Patient Outcome(s): Death
• Patient Age: 61 YR
• Patient Weight: 58