MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 g391 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g391 shows no trends.Trends were reviewed for complaint category, tubing 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

Customer called to report a hole in the anticoagulant line that was observed after an alarm #1: air detected warning occured during a treatment procedure.The customer stated that no whole blood was processed at the time the hole was observed.The customer stated that the treatment was aborted and that the patient was stable.The patient received treatment on another instrument the same day.The customer returned photographs for investigation.

Manufacturer Narrative

The customer returned photographs for investigation.A review of the photographs confirms a tear/cut in the anticoagulant line of the cellex photopheresis kit ("kit").A material trace of the tubing used to manufacture kit lot g391 did not identify any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.Kits are 100% leak tested prior to packaging, and a leak of this nature would have likely been detected during in-process testing.The root cause of the tubing leak is the tear/cut in the anticoagulant line.However, the cause of the tear/cut in the anticoagulant line could not be determined from the information provided.No further action is required at this time.This investigation is now complete.(b)(4).S.D.A.08/09/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster NJ 07921
• MDR Report Key: 8833406
• MDR Text Key: 209845127
• Report Number: 2523595-2019-00086
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G391(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: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• 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: G391
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Weight: 41