MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AMICUS SEPARATOR SYSTEM; AMICUS APHERESIS KIT

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/30/2022

Event Type  Injury  

Event Description

Initial mdr information: fresenius kabi received a report from a customer stating they had a 37 year old female patient undergoing deimmunization protocol for renal transplantation, with a live donor.During a centrifugal plasmapheresis session, after 25 to 30 minutes of processing: "blood leakage" alarm with visual presence of blood in the centrifuge spool occurred.There was no previous alarm or inconsistent pressure value before the blood leakage alarm.Reported patient status on september 5, 2022: restitution not made due to circuit breakage.Blood loss with risk of hypotension and anemia in a patient awaiting transplant.Delay in the management of the patient with reassembly of a new plasmapheresis circuit on a new device.Actions taken by the customer: device cleaned and isolated in the biomedical department.When the circuit was removed, a white ring used as a guide for the tubing was disconnected from its grey support, but no link was established with the tubing rupture responsible for the blood loss.Per follow-up with the customer, "the patient lost 1 hemoglobin point (8.4 g/dl on august 25th, 7.4 g/dl on august 26th).Hemoglobin continued to drop during the stay, leading to the transfusion of 2 packed red blood cells." per fresenius kabi medical device safety clinician, the healthy range for hemoglobin is: for men, 13.2 to 16.6 grams per deciliter for women, 11.6 to 15 grams per deciliter this patient was in the hospital for a kidney transplant and their hemoglobin would not fall within the normal range.A blood transfusion was required for the drop from 8.4 g/dl to 7.4 g/dl within one day.Although anemia is a known complication of kidney disease, the loss of blood (amount unknown) due to the device/kit issue exacerbated the problem.The patient was given 2 units of packed rbcs to mitigate the blood loss complications.The delay in therapy resulted in medical intervention being required.Follow-up mdr information: one sample was received for evaluation.The umbilicus on the returned sample was severely twisted and separated at the lower joint.A groove was worn into the umbilicus approximately 2-1/4" below the bearing.This abrasion damage is consistent with the umbilicus rubbing on the lower centrifuge arm.There was a kink and twist damage on the umbilicus approximately 4-1/4" below the bearing.This damage is consistent with the umbilicus contacting the front of the blue spool latch.The umbilicus was slightly twisted at the bearing and upper joint.Measurement of the position of the bearing on the umbilicus confirms it is in the proper location.The bearing was not damaged and can spin freely.There was a slight abrasion on the top of the separation side of the centrifuge pack approximately 4-1/2" to 5-1/2" from the end of the pack.The customer complaint was confirmed by the returned sample evaluation.Probable root cause of the reported incident is most likely related to an operator misload where the spool was not completely secured in the spool holder.The damage to the umbilicus is consistent with the spool coming out of the spool holder during operation causing the umbilicus to rub on the lower centrifuge arm.This condition can prevent the umbilicus from freely turning leading to twisting, damage, and failure.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.No trend was observed for this defect category.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: AMICUS APHERESIS KIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• MDR Report Key: 15546746
• MDR Text Key: 333120933
• Report Number: 3004548776-2022-00203
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 09/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Model Number: N/A
• Device Catalogue Number: R6R2339C
• Device Lot Number: FA21K29267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2022
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR
• Patient Sex: Female