MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AURORA XI PLASMAPHERESIS SYSTEM; AUTOMATED BLOOD CELL SEPARATORS

Model Number N/A

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

Patient Problems Sepsis (2067); Respiratory Failure (2484); Thrombosis/Thrombus (4440)

Event Date 12/20/2022

Event Type  Death  

Event Description

On may 12, 2023 biomat columbus reported a donor fatality which occurred on (b)(6) 2022.Donor was a 36-year-old male who had donated 99 times since (b)(6) 2019.Donor was 5'11" and 332 lbs.He was deferred 4 times for out-of-range pulse and diastolic blood pressure values between (b)(6) 2022.Last donation occurred on (b)(6) 2022.Donation was without complication and 894ml of plasma was collected.Donor received 500ml of saline after collection.The death certificate states the immediate cause of the donor's death to have been an acute respiratory failure, due to septic shock, as a consequence of an acute cerebral vascular accident, as a consequence of an acute deep vein thrombosis.No autopsy was performed.The aurora xi device was unable to be analyzed for the day of donation ((b)(6) 2022), as the fatality ((b)(6) 2022) was reported almost 5 months after the donation occurred.A technician did go to the site on may 17, 2023 and found the device to be working as intended.Batch review for the aurora xi kit was without exception.Based on missing the hospital admission date, missing medical records, and that the device was unable to be analyzed for the day of donation, there is not enough information to rule out the donation as a contributing factor.Other factors to consider are the donor's morbid obesity and family history of blood clots (per donor's girlfriend) as being significant contributors to the fatality.

Event Description

Initial mdr information: on may 12, 2023 biomat columbus reported a donor fatality which occurred on (b)(6), 2022.Donor was a 36-year-old male who had donated 99 times since (b)(6), 2019.Donor was 5'11" and 332 lbs.He was deferred 4 times for out-of-range pulse and diastolic blood pressure values between (b)(6) 2022 and (b)(6) 2022.Last donation occurred on december 05, 2022.Donation was without complication and 894ml of plasma was collected.Donor received 500ml of saline after collection.The death certificate states the immediate cause of the donor's death to have been an acute respiratory failure, due to septic shock, as a consequence of an acute cerebral vascular accident, as a consequence of an acute deep vein thrombosis.No autopsy was performed.The aurora xi device was unable to be analyzed for the day of donation ((b)(6) 2022), as the fatality ((b)(6) 2022) was reported almost 5 months after the donation occurred.A technician did go to the site on (b)(6), 2023 and found the device to be working as intended.Batch review for the aurora xi kit was without exception.Based on missing the hospital admission date, missing medical records, and that the device was unable to be analyzed for the day of donation, there is not enough information to rule out the donation as a contributing factor.Other factors to consider are the donor's morbid obesity and family history of blood clots (per donor's girlfriend) as being significant contributors to the fatality.Follow-up mdr information: no sample or pictures were received by fresenius kabi for evaluation.As a result, no conclusive or potential root cause of the event could be identified.A batch review was completed for material 6r2600, batch fa22i26042.No exceptions were generated that could classify as a possible root cause of this event.Fresenius kabi has made 3 attempts to contact the customer for further information.The last inquiry was made on june 09, 2023 requesting the hospital admission date.Based on the response from the customer, fresenius kabi has been informed that there is no additional information and that a formal request for the medical records has been made.As of the date of this report, fresenius kabi has not received the medical records.If the additional information is provided, a follow up shall be submitted.

• Brand Name: AURORA XI PLASMAPHERESIS SYSTEM
• Type of Device: AUTOMATED BLOOD CELL SEPARATORS
• 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: 17101018
• MDR Text Key: 316928904
• Report Number: 3004548776-2023-00169
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160028
• 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: 07/21/2023

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: 6R2600
• Device Lot Number: FA22I26042
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/09/2023
• Supplement Dates Manufacturer Received: 05/12/2023
• Supplement Dates FDA Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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