MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/06/2020

Event Type  malfunction  

Manufacturer Narrative

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 j328 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j328 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for these complaint categories.The customer returned photographs for investigation.A review of the photographs verify the centrifuge bowl broke as it is seen in multiple pieces at the bottom of the centrifuge chamber.The outer centrifuge bowl base appears to be intact and still secured in the bowl holder.The outer centrifuge bowl is in one large piece, indicating the outer centrifuge bowl most likely separated from the bowl base.A material trace of the bowl assembly and its components used to build lot j328 found no related non-conformances.A device history record review did not result in any related non-conformances.This lot passed all lot release testing.The cause of the alarm #7: blood leak? (centrifuge chamber) alarm is due to the centrifuge bowl break.The 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.This investigation is complete.(b)(4) s.D.A.05-nov-2020.

Event Description

The customer contacted mallinckrodt to report that they experienced a centrifuge bowl leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that 211 mls of whole blood was processed at the time the break occurred.The customer indicated that an alarm #7: blood leak? (centrifuge chamber) occurred.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The patient was reported to be in stable condition and began treatment on a different instrument.The customer returned photographs 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: 10793525
• MDR Text Key: 224807856
• Report Number: 2523595-2020-00116
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J328(17)220401
• Combination Product (y/n): Y
• 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: 11/05/2020

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: 04/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: J328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• 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: 69 YR
• Patient Weight: 100