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

Model Number NOT APPLICABLE

Device Problems Disconnection (1171); Leak/Splash (1354)

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

Event Date 03/16/2018

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 f133 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f133 for the reported issue 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 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 tubing leak during the treatment procedure.The customer stated the treatment ran smoothly until buffy coat collection started and the nurse observed plasma leaking around the hct sensor.The customer paused the instrument, lifted up the hct sensor and noted the tubing was disconnected from the cuvette.The customer stated no leaks were observed during the prime phase of the procedure.The customer stated they ended the treatment and returned blood from the centrifuge bowl to the patient.The customer stated the patient was stable.The customer has returned photographs for investigation.

Manufacturer Narrative

A photographic analysis was conducted for this complaint.The customer provided photograph verifies the tubing had disconnected from the hct cuvette component of the complaint kit.The tubing becoming disconnected indicates an insufficient bond between the tubing and the cuvette.The root cause of the becoming disconnected is most likely manufacturing operator error during the tube bonding process.Retraining has been completed for manufacturing operators who perform this operation.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2018.

• 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: 7429911
• MDR Text Key: 105906335
• Report Number: 2523595-2018-00056
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/23/2018

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: Nurse
• Device Expiration Date: 10/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/13/2018
• Supplement Dates Manufacturer Received: 04/16/2018
• Supplement Dates FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2017
• 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: 41 YR
• Patient Weight: 68