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

Model Number N/A

Device Problems Increase in Pressure (1491); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 07/23/2023

Event Type  Injury  

Event Description

Fresenius kabi received a report from the biomat (b)(6) center stating they are investigating a donor who experienced a post-donation cardiovascular event while at the center.The donor was transported to the nearest hospital for further evaluation and treatment.The donor was diagnosed with a transient ischemic attack.The day of the last donation was (b)(6) 2023.This incident occurred while the donor was on the aurora xi instrument (model 6r4612, serial number (b)(6)).After the first collection cycle, the instrument was unable to return cells due to a pressure spike that was unable to be resolved.The center team decided to perform a second venipuncture in order to return the donor's red blood cells.After the second venipuncture was performed, the donor asked the phlebotomist if she could speak with the medical staff upon completion because she was experiencing some tightness in her chest.The phlebotomist contacted a nurse to come evaluate the donor right away.When the nurse arrived, the donor was unresponsive with her eyes open.After several minutes, the donor started bouncing her left foot, but still remained unresponsive.The center staff immediately contacted 911.The donor remained unresponsive the remainder of her time at the donation center.The ambulance arrived and transported the donor to the hospital.The donor is 43 years old and donates regularly.Per the fresenius kabi technical service representative, no irregularities were found with the aurora xi instrument.The instrument is performing as intended.All log files and procedure records have been gathered.The batch record for the aurora xi kit used during the donation (material 6r2600, batch fa23d28386) 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.No additional complaints were reported for the aurora xi kit (material 6r2600, batch fa23d28386) with the condition of stroke/ injury/ transient ischemic attack as of (b)(6) 2023.The donor's medical history includes hypertension and seasonal bronchitis.The donor's medications include lisinopril and breo ellipta prn.To date, the center does not have details of the medical intervention taken at the hospital.The following was provided to fresenius kabi by the biomat medical director: the donor appears to have experienced a post-donation hypotensive adverse event.Given that the event occurred early during donation and based on the donor's vital signs at the time of the event, the most likely cause of the donor's hypotension and symptoms was vasovagal syncope.Although the donor verbally reported that she was diagnosed with a tia at the hospital, we have not been able to verify as the donor has not responded to our follow-up communication attempts.However, vasovagal syncope can cause transient symptoms that may mimic some symptoms that can be associated with a tia.The most common etiologies for tia are ischemia (local obstruction of an artery) and embolism (caused by a blood clot that traveled from elsewhere in the body, typically from the heart or from the carotid artery).It would be unlikely that either cause would be directly related to the plasmapheresis process.However, without formal medical records to review, it is not possible to know with certainty.Serious injury complaints are trended as part of the fresenius kabi plasma monthly product review process.Product field performance is continually monitored.Based on this monitoring, additional actions can be implemented as applicable.

Event Description

On october 12, 2023, the fresenius kabi senior director of quality received a request for additional information regarding this incident from the fda.The following information was submitted to the fda consumer safety officer on november 2, 2023.The questions asked by the fda and fresenius kabi's response to each question are stated below.1.Please provide a more complete description of this event including any relevant details surrounding the event.The following information was submitted within the initial mdr # 3004548776-2023-00295: fresenius kabi received a report from the biomat pittsburg, pa-western donor center stating they are investigating a donor who experienced a post-donation cardiovascular event while at the center.The donor was transported to the nearest hospital for further evaluation and treatment.The donor was diagnosed with a transient ischemic attack.The day of the last donation was 07/23/2023.This incident occurred while the donor was on the aurora xi instrument (model 6r4612, serial number (b)(6) after the first collection cycle, the instrument was unable to return cells due to a pressure spike that was unable to be resolved.The center team decided to perform a second venipuncture in order to return the donor's red blood cells.After the second venipuncture was performed, the donor asked the phlebotomist if she could speak with the medical staff upon completion because she was experiencing some tightness in her chest.The phlebotomist contacted a nurse to come evaluate the donor right away.When the nurse arrived, the donor was unresponsive with her eyes open.After several minutes, the donor started bouncing her left foot, but still remained unresponsive.The center staff immediately contacted 911.The donor remained unresponsive the remainder of her time at the donation center.The ambulance arrived and transported the donor to the hospital.The donor is 43 years old and donates regularly.Per the fresenius kabi technical service representative, no irregularities were found with the aurora xi instrument.The instrument is performing as intended.All log files and procedure records have been gathered.The batch record for the aurora xi kit used during the donation (material 6r2600, batch fa23d28386) was reviewed.No exceptions were generated that could classify as a possible root cause to this event.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.No additional complaints were reported for the aurora xi kit (material 6r2600, batch fa23d28386) with the condition of stroke/injury/transient ischemic attack as of 08/21/2023.The donor's medical history includes hypertension and seasonal bronchitis.The donor's medications include lisinopril and breo ellipta prn.To date, the center does not have details of the medical intervention taken at the hospital.The following was provided to fresenius kabi by the biomat medical director: the donor appears to have experienced a post-donation hypotensive adverse event.Given that the event occurred early during donation and based on the donor's vital signs at the time of the event, the most likely cause of the donor's hypotension and symptoms was vasovagal syncope.Although the donor verbally reported that she was diagnosed with a tia at the hospital, we have not been able to verify as the donor has not responded to our follow-up communication attempts.However, vasovagal syncope can cause transient symptoms that may mimic some symptoms that can be associated with a tia.The most common etiologies for tia are ischemia (local obstruction of an artery) and embolism (caused by a blood clot that traveled from elsewhere in the body, typically from the heart or from the carotid artery).It would be unlikely that either cause would be directly related to the plasmapheresis process.However, without formal medical records to review, it is not possible to know with certainty.Serious injury complaints are trended as part of the fresenius kabi plasma monthly product review process.Product field performance is continually monitored.Based on this monitoring, additional actions can be implemented as applicable.Clarification to the initial mdr as of november 1, 2023: the day of the donor's last donation and post-donation cardiovascular event was july 23, 2023.No additional complaints were reported for the aurora xi kit (material 6r2600, batch fa23d28386) with the condition of stroke/injury/transient ischemic attack as of november 1, 2023.Additional information completed after the submission of the initial mdr as of november 1, 2023: log files from the aurora xi instrument (model 6r4612, serial number (b)(6) were reviewed.However, the log files do not have a time stamp which tie back to the procedure in question per the customer's report of the time the procedure was performed.The log files were from later in the day and both indicate that the device was operating as expected.Along with the test procedure data sheet (tpds) and these log file reviews, the conclusion can be drawn that the device was operating as expected during the procedure earlier in the day.There was no evidence or indication of a hardware or system issue with the device.A review of the service records for the aurora xi instrument (model 6r4612, serial number (b)(6) fourteen months prior to the date of this complaint, found no same/similar service calls related to this event.A device history review (dhr) for manufacturing non-conformances of the aurora xi instrument (model 6r4612, serial number (b)(6) was completed.The records were examined to determine if any were related to the complaint being investigated.The dhr review determined there are no related non-conformances.There were no other incidents in production of this product that would have caused the reported issue.A search of capa's found no related issues.On site evaluation of the instrument was completed by fresenius kabi service personnel.The device is operating as expected.The customer reports that the device was operating as expected and there were no unusual anomalies associated with the reported event which are attributable to the device or disposables.Evaluation of the disposable products was not completed by fresenius kabi personnel as the components were not returned for evaluation.A batch review for the affected lots of disposables has been completed by the suppliers, all quality sampling and testing results were satisfactory.There is insufficient information to attribute the root cause of the reported event to the device or disposable set.Fresenius kabi has advised the customer to follow instructions for instrument use per the manual to prevent any issues and alarms.The biomat medical affairs team, report by the fresenius kabi medical device safety clinician and the device evaluation by the fresenius kabi service team determined that the device was functioning normally and did not contribute to the donor's cardiovascular event.Based on all currently available information, there is no evidence to suggest a causal relationship between the donation and the donor event.2.Please fully describe the reported device malfunction.Describe any relevant alarm states and visual and/or audible indicators the device should present when a malfunction of this nature occurs.After the first collection cycle, the instrument was unable to return cells due to a pressure spike that was unable to be resolved.Fresenius kabi does not believe the device malfunctioned but rather functioned as intended due to the donor's reaction.Per the fresenius kabi technical service representative, no irregularities were found with the aurora xi instrument.The instrument is performing as intended.3.Please provide any evaluation of the event described in the medical device report by the attending physician, surgeon, hospital representative or health care professional the following was provided to fresenius kabi by the biomat medical director: the donor appears to have experienced a post-donation hypotensive adverse event.Given that the event occurred early during donation and based on the donor's vital signs at the time of the event, the most likely cause of the donor's hypotension and symptoms was vasovagal syncope.Although the donor verbally reported that she was diagnosed with a tia at the hospital, we have not been able to verify as the donor has not responded to our follow-up communication attempts.However, vasovagal syncope can cause transient symptoms that may mimic some symptoms that can be associated with a tia.The most common etiologies for tia are ischemia (local obstruction of an artery) and embolism (caused by a blood clot that traveled from elsewhere in the body, typically from the heart or from the carotid artery).It would be unlikely that either cause would be directly related to the plasmapheresis process.However, without formal medical records to review, it is not possible to know with certainty.Fresenius kabi has not received additional information regarding any evaluation by the attending physician, surgeon, hospital representative or health care professional.4.Please provide complete patient information related to the reported event such as age, gender, medical history, relevant laboratory test results, patient's signs, and symptoms, and/or patient outcome the donor's medical history includes hypertension and seasonal bronchitis.The donor's medications include lisinopril and breo ellipta prn.To date, the center does not have details of the medical intervention taken at the hospital.Fresenius kabi has not received additional information regarding complete patient information.

• 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: 17617848
• MDR Text Key: 321928175
• Report Number: 3004548776-2023-00295
• 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: 11/03/2023

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: FA23D28386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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): Life Threatening
• Patient Age: 43 YR