MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Unintended Ejection (1234)

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

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pto leak.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 g395 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g395 shows no trends.Trends were reviewed for complaint category, pto leak.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 returned kit and photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a pump tubing organizer (pto) leak during an ecp treatment.The customer stated that approximately 402 ml of whole blood was processed at the time the leak occurred.The customer stated that the blood was contained within the pto but outside the pto filter.The customer agreed to abort the treatment without returning any residual blood from the kit.The patient was reported to be in stable condition.The customer provided photographs and returned the treatment kit for investigation.

Manufacturer Narrative

The complaint kit, photographs and the smart card were returned for analysis.Review of the smart card data determined there were no alarms experienced by the customer, and the treatment had been aborted after 402 ml of whole blood had been processed.A review of the customer provided photographs show that blood leaked out of the filter inside the pump tubing organizer (pto).Inspection of the returned pto found the weld between the filter cover and the pto base was not fully formed.The root cause of the pto filter leak was due to a poor weld between the filter cover and the base of the pto during the manufacturing process.A material trace of the bowl assembly and its components used to build lot g395 found no related non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.No further action is required at this time.This investigation is now complete.Mc: (b)(4).S.D.A.06/27/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster NJ 07921
• MDR Report Key: 8669783
• MDR Text Key: 147607578
• Report Number: 2523595-2019-00060
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G395(17)201201
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2019

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: 12/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 29 YR