MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 06/10/2020

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 h155 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h155 shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #55: collect pump (#1) error.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the photographs and kit with smartcard is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #55: collect pump (#1) error after approximately 1556 mls of whole blood was processed.The customer manually returned residual blood within the kit to the patient.The patient was reported to be in stable condition.The customer returned photographs and the kit with smartcard for investigation.

Manufacturer Narrative

The customer returned photographs and the kit with smart card for investigation.A review of the smart card data confirmed that the operator stopped the treatment after 1556 mls of whole blood had been processed.The data did not confirm the occurrence of an alarm #55: collect pump (#1) error as reported by the customer.A review of the customer provided photographs verifies the tubing leak as the recirculation pump loop/black stripe tubing has disconnected from the t-connector port.Inspection of the received kit showed a lack of solvent on the recirculation pump tubing where it is bonded to the t-connector port.The tubing is bonded to the t-connector during manufacturing.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The cause of the tubing becoming disconnected was most likely a weak solvent bond between the tubing and the t-connector.The root cause of the tubing leak was most likely a manufacturing operator error during the tube bonding process.Retraining has been completed for all bonding operators.No further action is required at this time.This investigation is now complete.(b)(4).S.D.A.(b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster, nj
• MDR Report Key: 10252282
• MDR Text Key: 247906674
• Report Number: 2523595-2020-00075
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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: 10/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/10/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1