MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl leak/break.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot h373 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h373 shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure, alarm #9: blood pump error, alarm #7: blood leak? (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for each complaint category.The customer returned the ecp treatment's smart card for evaluation.Review of the data recorded on the smart card verified the reported alarms by the customer.The data shows an alarm #17: return pressure alarm occurred at the beginning of the procedure, followed by an alarm #9: blood pump error alarm after 22 ml of whole blood had been processed.The treatment proceeded through the purging air phase and an alarm #7: blood leak? (centrifuge chamber) alarm occurred at 245 ml whole blood processed.The alarm #7 occurs when fluid is detected within the centrifuge chamber by the leak sensor.The alarm #7 most likely occurred due to the reported centrifuge bowl break; however, a root cause for the centrifuge bowl break could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #17: return pressure and alarm #9: blood pump error alarm early in the procedure.The customer stated they heard the sound of a clip coming loose in the centrifuge chamber before the centrifuge bowl broke.The customer received an alarm #7: blood leak? (centrifuge chamber) alarm and noticed the centrifuge bowl had detached from the bowl holder.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer returned the kit's smart card for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 10088371
• MDR Text Key: 198759817
• Report Number: 2523595-2020-00061
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H373(17)211101
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2020

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: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• 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