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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pulmonary Embolism (1498)

Event Date 04/13/2023

Event Type  Injury  

Event Description

Fresenius kabi great britain was informed of a serious adverse event (sae) that occurred in april.The national health service blood and transplant (nhsbt) birmingham plasma donor center was notified that a few days after donation, a donor presented in hospital with bilateral pulmonary embolism.There is no suggestion that the donation is part of the root cause but as part of nhsbt investigation they are looking at all possible causes.The donor contacted customer services to report that they had been diagnosed with bilateral pulmonary embolism 11 days post pfm donation.The donor advised cst they were admitted to hospital (b)(6) 2023 after symptoms of shortness of breath and chest pain.They (donor) have since found some research papers that may suggest increased risk of blood clots from plasma donation.The donor's discharge summary from hospital, sent to cst (b)(6) 2023, documented that donor had been feeling generally unwell for 4 weeks prior to admission to hospital.D/w donor medical team and lead nurse cst advised to raise as sae.The donor donated at least once a month and on some occasions twice monthly.His last donations were on (b)(6) 2023.He is a (b)(6) male.Nothing regarding the donor being unwell was noted on his donor safety check (dsc) and his donor primary nurse (dpn) stated that there were no issues during his donations.No sample or picture were received by fresenius kabi for evaluation.Therefore, no potential root cause of the event could be identified.A batch review was completed for material 6r2281, batch fa21l01058.No exceptions were generated that could classify as a possible root cause of this event.Fresenius kabi usa made three attempts for additional information, including the device's logfiles, with no response as of the day of this report.There is no indication that any adverse event occurred during the previous or most recent donation, nor has any issue with the device been reported.

• 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: 17346607
• MDR Text Key: 319255178
• Report Number: 3004548776-2023-00252
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 07/18/2023

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: 6R2281
• Device Lot Number: FA21L01058
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2023
• Initial Date FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2021
• 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): Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male