MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e346 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e346 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and drive tube leak/break.No trends were detected for these complaint categories.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned kit photos is still in progress.A supplemental report will be filed when the analysis of the kit photos is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report an alarm #7: blood leak (centrifuge chamber) alarm at approximately 509 ml of whole blood processed.The customer stated that the bowl and drive tube were still attached to the centrifuge frame, but they noticed a pin hole leak coming from the drive tube.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was in stable condition pre-procedure, during procedure, and post-procedure.The customer reported that the patient did not require any medical intervention.The customer reported that they were able to clean up the spill inside of the centrifuge chamber.The customer stated that all of the components inside the centrifuge chamber were undamaged, and they have already primed another kit on this instrument with no issues.Photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.The photos indicated that there was a leak on the floor of the centrifuge chamber and also along the centrifuge chamber's lower wall.The photos showed that the leak seemed to be concentrated around the drive tube especially where it meets the drive tube clamp.However, the exact location of the leak could not be determined based on the available information.The root cause of the leak could also not be determined based on the information provided.The device history record review did not result in any related nonconformances and this kit lot had passed all lot release testing.No further action required.This investigation is now complete.Correction device manufacture date: 08/31/2016.(b)(4) device not returned to manufacturer.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• 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 ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6214976
• MDR Text Key: 63839111
• Report Number: 2523595-2016-00293
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E346(17)180801
• 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: 12/29/2016

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: 08/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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
• Patient Age: 34 YR
• Patient Weight: 64