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

Model Number NOT APPLICABLE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2017

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 f323 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of f323 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.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photographs and returned kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report a centrifuge bowl leak/break during the treatment procedure.Customer stated the centrifuge bowl broke following the purging air/establishing separation phase of the procedure.Customer stated approximately 204 ml of whole blood was processed at the time of the break.Customer stated the patient is stable and has returned the complaint kit and photographs for investigation.

Manufacturer Narrative

Correction: user facility medwatch received.The kit and smartcard were returned for analysis.A review of the data on the smartcard identified that an alarm #7: blood leak (centrifuge chamber) occurred and alarm #18: system pressure alarm was received after 204 ml of whole blood was processed.The broken pieces of the centrifuge bowl were examined and determined the outer bowl cover weld joint was intact, indicating a weld failure was not likely to be the cause of the centrifuge bowl break.The returned drive tube assembly was evaluated and a small tear was observed near the upper bearing stop.The tear appeared to be a result of the bowl break; however, not the cause of the bowl break.A material trace of the bowl assembly and its components used to build kit lot f323 found no related nonconformances.No manufacturing related defects were confirmed during the evaluation.The investigation determined the cause of the bowl break was most likely a failure in the side wall of the centrifuge bowl.The root cause of the failure could not be determined.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• 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: 6842278
• MDR Text Key: 85949386
• Report Number: 2523595-2017-00166
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F323(17)190501
• 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: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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: 53 YR