MAUDE Adverse Event Report: FRESENIUS KABI WARRENDALE AMICUS SEPARATOR SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420); Defective Device (2588)

Patient Problems Exposure to Body Fluids (1745); Nausea (1970); Dizziness (2194); Pallor (2468)

Event Date 01/17/2023

Event Type  malfunction  

Event Description

Six complaints from the clinical sites in the past few months have gone unanswered from their quality department, despite emailing directly with the fresenius account executive-east coast with each complaint.Not all complaints available, some went directly from site to rep.Additional complaint file available but exceeds the limit for upload.Event #1 [redacted date].Situation: blood spill in the amicus machine during a therapeutic plasma exchange (tpex) background: tpex is a monthly procedure that the patient receives for fgfr3 antibody positive immune mediated neuropathy and lrp4 antibody positive myasthenia gravis.Assessment: patient was receiving their monthly tpex procedure, however at 82% of procedure completion, the amicus machine stated a message on the screen "leak in the centrifuge".Therefore, procedure was aborted.No rinse back of patient's blood in the machine was given back due to the leak.The patient was informed of the machine malfunction.Post procedure vital signs were stable, and patient was discharged in stable condition.Recommendation: possible cause may be kit malfunction.Therefore, the kit will be sent back to amicus/fresenius kabi manufacturer.Event #2 [redacted date].Situation: 82% into the plasma exchange, machine alarmed and indicated "centrifuge leak" background: patient was receiving her #4 plasmapheresis for immune mediated neuropathy.Assessment: 82% into the plasma exchange, machine alarmed and indicated 'centrifuge leak".Rn checked at the centrifuge and noted blood spill.Procedure was aborted, rinse back was not performed and informed patient what just happened.Patient disconnected from the machine and vs checked.While checking vs, rn noted patient turned pale and c/o dizziness and nausea.Patient placed on flat, lying position, legs elevated with a pillow and ice pack applied to chest with positive effect.Recommendation: report to manufacturer.Event #3 [redacted date].Situation: amicus kits recall not received by apheresis clinic despite it being ynhhs policy to send it to the recall administrator email address and recently reviewing this policy with fresenius, they failed to do so.Background: since december, we experienced multiple blood spills during procedures with our amicus machines.It involved (two) different lot numbers.These events were reported to the company manufacturing the kits, fresenius-kabi.Despite multiple events and follow-up, we did not receive any investigation results from fresenius on these events.Fresenius came to service the machine and confirmed the spills were not the result of an issue with the machine.We experienced two blood spills on two patients, using different machines.We called to report the events to fresenius (6 events since december) and were told the kits we are using have been recalled and should not be used.A letter was sent by fedex to centers by fresenius on [redacted date].Assessment: proof of delivery to ynhh on [redacted date] was provided by fresenius.However, as of [redacted date], the apheresis unit has not been notified of the recall.Fresenius quality team did not follow-up on the reports sent, despite the recall and did not send the letter directly to the apheresis unit or leadership apheresis charge rn and manager have been in communication with fresenius and obtained a copy of the recall letter.This recall impacts multiple lot number and all of the kits we have in stock.Manager sent an email to operations coordinator to assist in getting the message to other locations in the health system using amicus machines, including l&m.Also, as a result, the apheresis unit is down two additional machines, which will impact patient care.Recommendation: schedule will be reviewed and patients will be rescheduled as needed.Manager will follow-up internally regarding this recall manager is currently following up with fresenius-kabi to review the correct process for notification of the apheresis unit in real time and requesting an investigation report on the events reported to the quality team.The apheresis needs to buy new machines in order to have back up for these events and sustain patient care.An sbar has already been provided to leadership for the purchase.Event #4.Situation: 87% into tpex procedure notification of blood spill in machine appeared on screen.Background: patient came into clinic for routine tpex procedure.Twenty minutes left to the procedure; a message appeared on the screen stating there is a leak in the centrifuge.Procedure was stopped and rinse back was not able to be performed.Assessment: patient was not harm during the spill.Vss.Apheresis team was notified.Report sent to fresenius-kabi regarding defective kit.Fresenius-kabi made charge rn aware that the kits used had been recalled.No recall letter was received by apheresis.Recommendation: remove amicus machine from unit, call the company to service machine.Manufacturer response for apheresis kits, amicus kits (per site reporter) six complaints were submitted since december and then our sites were not notified when there was a recall despite persistent follow up from clinical sites to northeast rep and cell transfusion specialist from fresenius-kabi.Failure to comply with health system recall policy as well, which had recently been reviewed with the company.

• Brand Name: AMICUS SEPARATOR SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• Manufacturer (Section D): FRESENIUS KABI WARRENDALE; 770 commonwealth dr; warrendale PA 15086
• MDR Report Key: 16572329
• MDR Text Key: 311583476
• Report Number: 16572329
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/20/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1