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 10/13/2019

Event Type  Injury  

Event Description

Medical intervention after donation.

Event Description

On (b)(6) 2019 the phlebotomist evaluated two hb detect alarms for donor (b)(6).The first hb detect alarmed and bubbles were noted in the plasma line.Once alarm advanced the plasma color appeared to go back to a more yellow color.After a period of time, a second hb detect sounded, the plasma appeared amber in color and the procedure was terminated.The donor did not receive rbcs or saline, however was provided gatorade during wait time.Donor was monitored and released feeling well and healthy.On (b)(6) 2019 the center received a call from the donor reporting blood in urine throughout the evening of (b)(6) 2019 and into the next day.Donor was advised to seek medical attention as soon as possible at local emergency room (er).On october 16, 2019 staff called donor for follow-up and donor stated she went to the er and was placed on antibiotics.Donor reported no further blood in urine, and she feels much better.Instructed donor to call center if any changes and to bring medical documents into the center for review.The donor reaction report on october 13, 2019 indicated the donor experience hb detect alarm x2 and was referred to the mss for rbc loss of 63 ml.The volume of plasma collected was 796 ml, the color of the plasma was amber.The disposable kit was discarded into the bio-hazardous waste receptacle after the donation and is not available for evaluation.The aurora instrument in use during the incident was taken out of service 10/14/2019 and evaluated by the center on 10/15/2019 with no issues noted.Unable to get the diagnosis for the reason the donor was put on antibiotics when they went to the er for discolored urine.It is most likely that it was for a possible urinary tract infection, although there is no way to confirm this after several attempts at follow-up.Findings: no sample or picture available for analysis but based on the problem code description and recent investigation the red plasma / hb detected reported could be associated to an incomplete membrane seal or a damage pivot on the spinner device.Customer complaint is confirmed root cause: the root causes identified for the membrane seal are related to the gate insert of the injection molding machine had signs of wear and that the rotor body molding process normal variation was affecting the spinner machine setting.For the damage pivot the root causes found by the investigation process were related to the angle of the photo posted on the work instruction for the short shot reference was not adequate, manufacturing fixture used did not have an angle which allow to inspect the pivots side views and the 100% pivot inspection was affected as a result of the constant magnifier adjustment.Current controls: to assure integrity of the kit, following controls are established at manufacturing site: 1) 100% manufacturing pivot visual inspection.2) in process sampling quality pink bead (autopsy).3) post sterilization sampling final inspection.Corrective action: replace gate insert of cavities 1,5 and 9.Develop a rotor cavity segregator at injection molding machines to maintain individual cavity packages and reduce sealing variation.Update work instructions related to pivot inspection wi-mf-032418125 to improve current visual aids.Improve fixture for pivot inspection, including an angle to ensure all pivot views verification.Define individual stations according to the required resolution for pivot inspection.Exception generated: the batch record fa19h26395 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.

• 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: 9330133
• MDR Text Key: 167612435
• Report Number: 3004548776-2019-00025
• 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: 10/18/2019

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: FA19H26395
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2019
• Event Location: Other
• Date Report to Manufacturer: 10/18/2019
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 10/18/2019
• 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