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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematuria (2558)

Event Date 09/07/2023

Event Type  Injury  

Event Description

Fresenius kabi germany reported an incidence of hemolytic plasma during a donation on the aurora plasmapheresis system.The donor experienced discolored urine and was sent to the hospital.Samples have been returned for evaluation and the device log files are being reviewed.A follow-up mdr will be filed once the investigation of this event is complete.

Event Description

Sample evaluation findings: -one customer photo shows the plasmalink pooling bottle containing plasma with a red discoloration; -one customer photo shows a blood contaminated kit installed on the instrument; the plasma line contains plasma with a red discoloration; -two customer photos show filled test tubes containing liquid with a red discoloration; -the blood pump tubing between y2 connector and y3 connector was measured approximately 7-6/8", as per the drawing, this is within the tolerance of 7-5/8" +/- 1/8"; -the blood pump tubing (the tubing between y2 and y3) installs properly in the pump and is visually not too long; -the contents of the kit were drained out for further blood analysis; -no scrape marks were found on the rotor and inside the case; -no leaks were found in the rotor membrane; -there was a nonconcentric impression wear on the seal ring from the eyelet, indicating a misalignment of the rotor to the case/pivot; -the pivot showed moderate and uneven wear; -approximately half of the rim of the eyelet flange formed a wide ridge; -the dental cast of rotor bearing cavity showed no deformation or defects; -the ovality test was passed; -the i.D.Of the case plasma port was concentric to the o.D.Customer's complaint is confirmed.The batch record for product code 6r2262, lot fa23f05306 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.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, the following controls are established at the disposable manufacturing site: -in process sampling quality inspection; -post sterilization sampling final inspection; -quality and manufacturing inspection.Track and trend: fresenius kabi received a total of 2 discolored urine incidents against product code 6r2262, lot fa23f05306.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints or to determine if corrective actions are needed.An adverse trend was observed for this defect category.Capa 1700421 was issued to perform the applicable investigation and identify corrective actions.Root cause identified in capa 1700421: the primary root cause is the surface finish of the pin, which can create friction that stops the roller.The stopped roller pulls tubing, creating a kink.If the roller stoppage occurs on the blood pump and the kink occurs on return, hemolysis is not immediately detected, leading to discolored urine.Confounding factors include application of silicone lubricant, which increases the likelihood of roller stoppage and long/stretched/twisted tubing, which increases the likelihood of a kink.Corrective action: the following corrective actions were defined in capa 1700421: -improved detection of roller cages at risk of having a stuck roller; -improvement of current roller pin surface finish; -to instruct operators and service technicians not to use lubricants on the roller cages.

• 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: 17837409
• MDR Text Key: 324515831
• Report Number: 3004548776-2023-00336
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK110072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2024

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: 6R2262
• Device Lot Number: FA23F05306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 09/08/2023
• Supplement Dates FDA Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2023
• 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): Hospitalization