MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Fragmentation (1261); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunctions centrifuge bowl leak/break, drive tube leak/break.Since these reportable malfunctions are only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot f333 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of f333 for the reported issue shows no trends.Trends were reviewed for complaint categories alarm #7: blood leak (centrifuge chamber), centrifuge bowl leak/break, drive tube leak/break.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photos is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer has called to report an alarm #7: blood leak (centrifuge chamber), which sounded a moment after the customer heard the centrifuge bowl and drive tube break.The customer mentioned that the breaks had occurred while the centrifuge bowl was rotating full speed at approximately 250 ml whole blood processed.The customer immediately aborted the procedure, and did not return any blood from the instrument to the patient.Customer said the centrifuge bowl was shattered and that the drive tube had severed just above the lower drive tube bearing.Customer confirmed that there was no blood exposure to the patient, any staff member, or any bystander.Customer said the patient was stable before, during, and after the incident occurred.The patient was able to tolerate the blood loss and no medical intervention, blood transfusion, or saline bolus was required.The patient was able to receive a successful treatment on a new kit and different instrument.The customer provided photographs to be investigated for this incident.

Manufacturer Narrative

The customer provided photographs have been returned for investigation.The photographs provided verify that the drive tube and centrifuge bowl had broken during the procedure.Further analysis of the photographs show the bowl was shatter at the bottom of the centrifuge chamber and drive tube was to both be broken above the lower bearing stop.The upper drive tube bearing clip was found to be in open position while the lower drive tube bearing clip is in closed position.The customer description and provided photographs was not enough information to determine a root cause of the incident.No further actions are required.Investigation complete.Investigation complete.(b)(4).A.B: (b)(6) 2017.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6922049
• MDR Text Key: 90037666
• Report Number: 2523595-2017-00181
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F333(17)190701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/06/2017
• Supplement Dates Manufacturer Received: 10/18/2017
• Supplement Dates FDA Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2017
• 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 Age: 51 YR
• Patient Weight: 68