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

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 08/05/2019

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 h107 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h107 for the reported issue shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.A review of the photographs verify the centrifuge bowl break as blood is seen on the centrifuge chamber walls and at the bottom of the chamber.The base of the outer centrifuge bowl appears to be mostly intact and is still contained within the bowl holder.A material trace of the bowl assembly and its components used to build lot h107 found no related nonconformances.A device history record review of kit lot h107 did not identify any related non-conformances, and this kit lot had passed all lot release testing.The cause of the centrifuge bowl break was most likely a break in the centrifuge bowl material; however, the root cause for the break in the material 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 called to report a centrifuge bowl leak/break during an ecp treatment.The customer reported approximately 257 ml of whole blood was processed at the time the break occurred.The customer aborted the procedure and did not return residual blood within the kit to the patient.The customer reported the patient was stable.The customer discarded the cellex photopheresis kit; however, has returned photographs for evaluation.

• 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: 8966038
• MDR Text Key: 193966684
• Report Number: 2523595-2019-00098
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/05/2019

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: 02/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2019
• Initial Date FDA Received: 09/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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
• Patient Age: 58 YR
• Patient Weight: 74