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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/04/2023

Event Type  Injury  

Event Description

(b)(6) received a report regarding an adverse event during an amicus donation.During the donation, the lower middle tube of the right cassette fell out of the cassette when the procedure was 87% complete.No alarm occurred.The nurse discovered the tubing issue and the donor noted they were "uncomfortable".The nurse terminated the donation.Donor blood pressure: 115/65, heart rate 85 bpm at 14:33.Blood pressure: 95/56, heart rate 80 bpm at 15:01.Donor was pale faced, high breath rate - 26~32/min.Donor had a low-volumetric shock and was sent to hospital emergency department to do medical procedure.At the hospital, the donor had 'proceed' medical procedure, blood pressure returned to 134/92, heart rate 76 bpm upon arrival at the hospital.The donor stayed in the hospital emergency room for 4 hours and then returned home.Follow-up was made to the customer to determine what is meant by "medical procedure" was required, if meds were administered, donor's diagnosis, donor's medical history, donor's current medications, donor's discharge information, and any donor status follow-ups made.Per customer, the donor does not consent to provide more detailed information.Per (b)(6) clinician, based on the limited information provided, the donor went to the er and was discharged to home in good condition in less than 4 hours.It appears that they were experiencing hypovolemia with low blood pressure due to the loss of an unknown amount of blood.Bp was 115/65, then 95/56 when they were taken to the er.They likely were given iv fluids and their bp was returned to 134/92 in the emergency room.Unknown "medical procedure", unknown medical history, unknown medications, and unknown diagnosis from the emergency room visit.(b)(6) has not received additional complaints for amicus disposable product x6r2312, batch fa22i28147.Batch record for the amicus disposable product x6r2312, batch fa22i28147 was reviewed with satisfactory results.(b)(6) is reporting this event as a precaution since it is not known what was performed during the 4 hours the donor was in the hospital.

Event Description

Initial mdr information: fresenius kabi received a report regarding an adverse event during an amicus donation.During the donation, the lower middle tube of the right cassette fell out of the cassette when the procedure was 87% complete.No alarm occurred.The nurse discovered the tubing issue and the donor noted they were "uncomfortable".The nurse terminated the donation.Donor blood pressure: 115/65, heart rate 85 bpm at 14:33.Blood pressure: 95/56, heart rate 80 bpm at 15:01.Donor was pale faced, high breath rate - 26~32/min.Donor had a low-volumetric shock and was sent to hospital emergency department to do medical procedure.At the hospital, the donor had 'proceed' medical procedure, blood pressure returned to 134/92, heart rate 76 bpm upon arrival at the hospital.The donor stayed in the hospital er for 4 hours and then returned home.Follow-up was made to the customer to determine what is meant by "medical procedure" was required, if meds were administered, donor's diagnosis, donor's medical history, donor's current medications, donor's discharge information, and any donor status follow-ups made.Per customer, the donor does not consent to provide more detailed information.Per fresenius kabi pmqa clinician, based on the limited information provided, the donor went to the er and was discharged to home in good condition in less than 4 hours.It appears that they were experiencing hypovolemia with low blood pressure due to the loss of an unknown amount of blood.Bp was 115/65, then 95/56 when they were taken to the er.They likely were given iv fluids and their bp was returned to 134/92 in the er.Unknown "medical procedure", unknown medical history, unknown medications, and unknown diagnosis from the er visit.Fresenius kabi has not received additional complaints for amicus disposable product x6r2312, batch fa22i28147.Batch record for the amicus disposable product x6r2312, batch fa22i28147 was reviewed with satisfactory results.Fresenius kabi is reporting this event as a precaution since it is not known what was performed during the 4 hours the donor was in the hospital.Follow-up mdr information: no additional information has been received regarding the donor's visit to the hospital.Fresenius kabi has completed the evaluation of the reported malfunction.One sample was received for evaluation.After visual inspection and microscopic examination of the returned sample, the following observations were made: ·a detached return line was found from port #4 of the left cassette.·the separated return line was returned for evaluation.·few traces of solvent were observed on the return line and on port #4 of the left cassette.The customer complaint of the tubing falling out of the cassette was confirmed.Probable root cause of the reported incident is most likely related to the application of insufficient solvent during the manufacturing process.The manufacturing operator did not perform the bonding operation properly and a lack of solvent occurred between port #4 of the left cassette and the return line.To ensure this condition does not occur, the following current controls are in place during manufacturing: - in-process quality inspection - kit sampling during final physical testing which includes an underwater leak test.- 100% visual inspection is performed at the end of the manufacturing line and post-sterilization area.- a visual aid is posted at each station illustrating the correct assembly process on the manufacturing line.No further investigation or actions are required at this time.

• 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
• 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: 16352261
• MDR Text Key: 309282007
• Report Number: 3004548776-2023-00051
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: BK960005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/27/2023
• Device Model Number: N/A
• Device Catalogue Number: X6R2312
• Device Lot Number: FA22I28147
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention