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

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pump tubing organizer (pto) 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 g323 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot g323 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #16: collect pressure and pto leak.No trends were detected for each complaint category.The kit was returned for investigation.Examination of the returned kit showed no signs of a leak from the return filter.The return line was pressure tested and no liquid came out of the return line or the filter.The pto and return line were pressurized and held under water, no bubbles emerged from the return filter or the return line.Pressure testing of the return line and filter did not find any leaks or flow restrictions.The root cause of the reported pto leak 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 pump tubing organizer (pto) leak during the treatment procedure.The customer stated they received several alarm #16: collect pressure alarms at the beginning of treatment.The customer reported they collected about 100 ml of whole blood before they decided to abort the treatment due to the collect pressure alarms.The customer stated when they were unloading the kit, they noticed saline was leaking from the blood filter.The customer stated the patient was stable and was started on a new treatment.The customer has returned the kit 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: 7728652
• MDR Text Key: 115529040
• Report Number: 2523595-2018-00120
• Device Sequence Number: 0
• Product Code: LNR
• 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: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G323
• 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: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2018
• 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