MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NTO APPLICABLE

Device Problems Material Fragmentation (1261); Device Displays Incorrect Message (2591)

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

Event Date 06/26/2017

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 e348 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of e348 for the reported issue shows no trends.Trends were reviewed for complaint categories centrifuge bowl leak/break, alarm #17: return pressure.No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned kit and customer photos are still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer has called in to report a centrifuge bowl break in the very last moments of elutriation during the buffy coat collection.The customer stated that the only alarms received earlier on in the procedure was an alarm #17: return pressure and it was resolvable.Customer said the centrifuge bowl was found to be broken just as the hematocrit sensor graph reached 24%.The customer had hit the stop button and turned the instrument off and they do not remember hearing an alarm while doing so.The customer confirmed that they aborted the treatment, and did not return any blood or fluids to the patient.Customer said the patient was stable and would not require any medical intervention, blood transfusion, or fluid bolus.It was stated that the centrifuge bowl was "shattered," the base of the centrifuge bowl was still connected to the bowl holder.Customer said it appeared that the centrifuge bowl came apart at the very bottom plastic weld of the outer clear plastic bowl.Customer also mentioned the leak detector strip was damaged.The customer stated the bottom drive tube bearing remained installed in the retainer clip, but the upper drive tube bearing had dislodged from the upper bearing retainer clip.The customer stated that they will be returning the kit and providing customer photos.

Manufacturer Narrative

The complaint kit, smartcard and customer provided photographs were returned for analysis.Review of the smartcard determined that prime was completed without incident and verified the occurrence of the return pressure alarm early on during the treatment.Further review of the smartcard determined that buffy coat collection had begun after 1465 ml of whole blood was processed and a blood leak alarm in the centrifuge occurred shortly afterwards which verifies the customer's description of events.Evaluation of the returned kit components confirmed that the welded portion of the outer centrifuge bowl was intact.In addition, all four of the centrifuge bowl locating tabs are present and undamaged indicating the base was retained in the instrument's centrifuge bowl holder during the treatment.No issues or defects with the drive tube or the drive tube components were identified.The investigation was unable to determine a definitive root cause for the reported centrifuge bowl break.No manufacturing related defects were confirmed during the evaluation.Investigation complete.Mc: (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: 6743348
• MDR Text Key: 81433038
• Report Number: 2523595-2017-00134
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E348(17)180901
• 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: 08/24/2017

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: 09/01/2018
• Device Model Number: NTO APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/26/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• 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: 37 YR
• Patient Weight: 112