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

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2018

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 g317 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g317 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #1: air detected and tubing leak.No trends were detected for each complaint category.The kit and smartcard were returned for investigation.A review of the data recorded on the smartcard verified an alarm #1: air detected alarm occurred during the procedure.The returned kit was examined and showed no signs of a liquid leak.The collect line and anticoagulant line tubing of the kit were pressure tested.Both lines were pressurized and no bubbles were seen moving inside of the tubing.Testing of the collect and anticoagulant lines did not result in any leaks.The root cause of the tubing leak reported to have occurred at the connection between the cellex kit collect line and hospital's tubing extender could not be determined as no cellex kit defect could be identified upon evaluation of the returned product.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated they received an alarm #1: air detected alarm during the procedure.The customer stated there was air in the collect line due to the patient's access.The customer reported the collect line was connected to an extender which was connected to the patient's access.A blood leak was observed at the connection between the collect line and the extender.The customer reported approximately 270 ml of whole blood was processed at the time the leak occurred.The customer stated they disconnected the line and reconnected it, resulting in air bubbles in the collect line.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned the kit and smartcard for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7716087
• MDR Text Key: 115276015
• Report Number: 2523595-2018-00115
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G317(17)200201
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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