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

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 11/19/2018

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 g346 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot g346 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #18: system pressure.No trends were detected for each complaint category.Photographs were returned for evaluation.A review of the customer provided photographs confirm the tubing leak as blood is seen in the pump head location and pump tubing loop.The damage to the tubing is consistent with damage caused by improper installation of the pump loop tubing into the pump head.During installation of the kit by the end user if the pump loop is forcefully rubbed against the pump head it can result in scraping and potentially cutting the tubing loop as the pump head rotates.A material trace of the tubing used to manufacture lot g346 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.Cellex kits are 100% leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the tubing damage was present at the time of manufacture.The investigation determined the root cause of the tubing leak was most likely improper installation of the pump loop by the end user.No manufacturing related defects were identified through this investigation.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 #18: system pressure alarm at 321 ml whole blood processed and noticed a leak coming from the collect pump tubing segment.The customer stated there appears to be a slit in the tubing segment.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned photographs 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: 8182671
• MDR Text Key: 131796697
• Report Number: 2523595-2018-00174
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G346(17)200701
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• 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
• Patient Age: 62 YR
• Patient Weight: 93