MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AURORA PLASMAPHERESIS SYSTEM

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/27/2021

Event Type  Death  

Event Description

Donor was a (b)(6) male, 6' tall and (b)(6) lbs.Total # of donations were 95, beginning in 2018.Per customer, approximately one hour after completing a donation at the center on (b)(6) 2021, the donor was found in his car in the parking lot of the donor center unconscious and pulseless.Resuscitation attempts were made by both the medical center staff and the (b)(6) fire department paramedics but were unsuccessful.The donor was pronounced deceased at 3:19 pm.The preliminary impression from the medical examiner-coroner's office based on the investigation thus far, is that this may represent an accidental drug overdose.At the time of this report, the official autopsy results and the toxicology report have not been made available to fresenius kabi.If received, this conclusion will be re-assessed.Detailed review of the donation records dating back to (b)(6) 2021 revealed that the donor's donations were well tolerated.The donor had no documented adverse events during his entire donation history.No deferral trends were noted.In general, it appears that the donor tolerated the plasmapheresis procedure well.The device was evaluated, and no device malfunctions were observed.Batch reviews were without exception.Fresenius kabi has not found any evidence suggesting the aurora plasmapheresis system had any causality with the donor fatality.However, at this time, fresenius kabi is choosing to report conservatively as the official autopsy results and the toxicology report have not been made available to fresenius kabi.

Event Description

Initial mdr information: donor was a 40-year-old male, 6' tall and 196lbs.Total # of donations were 95, beginning in 2018.Per customer, approximately one hour after completing a donation at the center on (b)(6) 2021, the donor was found in his car in the parking lot of the donor center unconscious and pulseless.Resuscitation attempts were made by both the medical center staff and the los angeles fire department paramedics but were unsuccessful.The donor was pronounced deceased at 3:19 pm.The preliminary impression from the medical examiner-coroner's office based on the investigation thus far, is that this may represent an accidental drug overdose.At the time of this report, the official autopsy results and the toxicology report have not been made available to fresenius kabi.If received, this conclusion will be re-assessed.Detailed review of the donation records dating back to 03/19/2021 revealed that the donor's donations were well tolerated.The donor had no documented adverse events during his entire donation history.No deferral trends were noted.In general, it appears that the donor tolerated the plasmapheresis procedure well.The device was evaluated, and no device malfunctions were observed.Batch reviews were without exception.Fresenius kabi has not found any evidence suggesting the aurora plasmapheresis system had any causality with the donor fatality.However, at this time, fresenius kabi is choosing to report conservatively as the official autopsy results and the toxicology report have not been made available to fresenius kabi.Follow-up mdr information: no aurora kit sample or picture were made available for analysis.No contibuting cause can be identified, as no defects in material or batch were found.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints or to determine if corrective actions are needed.No trend was observed for this defect category.The aurora kit batch record fa21f30017 was reviewed.No exceptions were generated that could classify as a possible root cause.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.The pooling bottle batch record fa21g05108 was reviewed.No exceptions were generated that could classify as a possible root cause.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.The customer reported that sodium citrate solution product lot 21jg04018 was involved in the reported event which resulted in a donor fatality; however, there is no allegation of product deficiency.There were no samples or pictures provided by the customer for evaluation.The review of the batch production record and retain samples was performed where no failures were observed; therefore, the most probable conclusion is that the event was not related to a product deficiency.At the time of this report, the official autopsy results and the toxicology report have not been made available to fresenius kabi.Fresenius kabi has not found any evidence suggesting the aurora plasmapheresis system had any causality with the donor fatality.

• Brand Name: AURORA PLASMAPHERESIS SYSTEM
• Type of Device: AURORA PLASMAPHERESIS SYSTEM
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 12712258
• MDR Text Key: 278807748
• Report Number: 3004548776-2021-00141
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: BK110072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 4R2256
• Device Lot Number: FA21F30017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death