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

Lot Number E119A-KIT

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Device Displays Incorrect Message (2591)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e119a was conducted.There were no nonconformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, bag leak, alarm #21: air detector test failure, and centrifuge bowl leak/break.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.The analysis of the returned kit and smart card is still in progress.A supplemental report will be filed when the analysis of the kit and smart card is complete.(b)(4).

Event Description

The customer reported that there was a "big hole" in the bottom of the return bag, and they wanted to abort the treatment.The customer stated that they didn't notice the hole in the return bag until the purging air phase of the treatment when the instrument wouldn't return to the patient.The customer reported that they did not receive any alarms during prime or after the treatment had started.The customer stated that they also did not notice any priming fluid underneath the return bag.The customer reported that the only alarms that did occur were repeated alarm #21: air detector test failure alarms when trying to remove the kit after aborting the treatment.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient was in stable condition.The kit was received on 09/29/2016, and the customer's product declaration sheet which was attached to the kit stated that "when removing the kit, the centrifuge bowl was also found to be leaking." the kit was returned for investigation.

Manufacturer Narrative

The kit and smartcard were returned for analysis.A review of the smartcard data indicated that prime was successfully completed and blood collection had started.The purging air phase was completed after 194 ml of whole blood processed.An alarm #9: blood pump error alarm then occurred.The customer cycled power after 215ml of whole blood processed and several alarm #21: air detector alarms occurred.The treatment was then aborted.An examination of the return bag confirmed the leak.The examination indicated that the return bag's seal was open along the length of the bottom of the bag.The customer also stated that the centrifuge bowl had leaked while removing the kit.The centrifuge bowl was pressure tested in order to check for leaks, and no leaks were found.Thus the centrifuge bowl leak complaint could not be confirmed.The cause for the return bag leak was that the seal had opened at the bottom of the bag due to a welding issue.The root cause for the welding issue could not be determined.A capa was initiated at the manufacturing site in order to determine the root cause of this weld issue.A formal re-training was also conducted with those who perform this operation on both the return and treatment bags.The training was completed on october 18, 2016.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5999226
• MDR Text Key: 57271680
• Report Number: 2523595-2016-00226
• Device Sequence Number: 1
• Product Code: LNR
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2016

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: 04/01/2018
• Device Lot Number: E119A-KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2016
• Initial Date FDA Received: 10/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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