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

Model Number CLXUSA

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

Patient Problem Blood Loss (2597)

Event Date 09/29/2020

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 j317 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot j317 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 complaint kit was returned for evaluation.The smart card was not returned; therefore, the reported alarm #7: blood leak? (centrifuge chamber) could not be verified.Examination of the received kit verified a centrifuge bowl break had occurred as the centrifuge bowl was received in multiple pieces.Further examination determined that several broken pieces of the outer centrifuge bowl were not returned; therefore, the analysis was limited to the components available for inspection.The centrifuge bowl base was mostly intact.The bowl base had a large piece of the outer bowl still attached to it.The available outer bowl pieces were examined and determined that the outer bowl and bowl base had separated.The separation occurred above the weld joint indicating the separation occurred in the outer bowl material and not at the weld.A material trace of the bowl assembly and its components used to build lot j317 found no related non-conformance's.A device history record review did not identify any related non-conformance and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl break was most likely a break in the outer bowl material; however, the cause for the break in the outer bowl 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).P.T.(b)(6) 2020.

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 approximately 214 ml of whole blood was processed at the time the centrifuge bowl break occurred.An alarm #7: blood leak? (centrifuge chamber) alarm was received.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 and would begin a new ecp treatment with a new kit.The customer returned the complaint kit 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: 10747641
• MDR Text Key: 214804309
• Report Number: 2523595-2020-00112
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J317(17)220301
• 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: 10/28/2020

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: 03/01/2022
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: J317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2020
• 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: 45 YR
• Patient Weight: 101