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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 10/11/2019

Event Type  Injury  

Event Description

Donor experienced a head injury sustained after loss of consciousness, which resulted in a ct scan (most likely with contrast).

Event Description

Donor experienced a head injury sustained after loss of consciousness, which resulted in a ct scan (most likely with contrast).Ct scan was negative.Per email received from the customer on 10/14/2019, "following a clot in the reservoir being discovered after the cells were emptied from it, the donor was escorted with our nursing staff to the front.The donor requested to use the restroom and experienced a loss of consciousness in the restroom, resulting in him falling and hitting his head on the floor.Ems was called to evaluate and was taken off site for further analysis.No further information about him is known at this time.Follow up was made to see if medical intervention was received in the hospital.Per email from customer on 10/17/2019, "the donor was taken to the hospital and was evaluated there.Ct scan was negative and was released asymptomatic from the hospital." the donor required the medical intervention of a ct scan to rule out concussion, subdural hematoma and/or skull fracture.A scan to detect a brain bleed would have most likely used a contrast dye via iv to highlight the arteries and veins.The scan was negative, and the donor was released without symptoms.No further information is available at this time.Findings: no sample or picture available for analysis.Root cause: root cause cannot be identified based on the kit autopsy, due to no sample is available.Exception generated: the batch record fa19h23012 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.Quality test results: the finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Current controls: to assure integrity of the kit, following controls are established at manufacturing site: 1) in process sampling quality inspection.2) post sterilization sampling final inspection.

• 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
• MDR Report Key: 9296852
• MDR Text Key: 165647272
• Report Number: 3004548776-2019-00026
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK110072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 10/11/2019

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: FA19H23012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2019
• Event Location: Other
• Date Report to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 10/11/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 10/11/2019
• Supplement Dates FDA Received: 01/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other