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

Lot Number D312 - KIT

Device Problems Air Leak (1008); Crack (1135); Fluid/Blood Leak (1250); Split (2537)

Patient Problem Blood Loss (2597)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d312 was performed.There were no nonconformances related to the complaint.This lot met release requirements.The uvadex lot number was not provided, since uvadex was not administered.However, a review of all uvadex lots manufactured since (b)(6) 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, tubing leak and tubing - length.No trends were detected.However, a capa has already been initiated for tubing - length.Evaluation of the returned kit is still in progress at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).

Event Description

Customer reports blood leak from split/"crack" in tubing at the joint where the collect pressure transducer is connected to the tubing segment coming from the pump tube organizer.Customer reports at approximately 330 ml whole blood processed, the operator observed air entering kit tubing at the joint of the pressure transducer and tubing segment, followed by blood leaking from tubing at same location.Customer reported clamping patient lines, stopping bowl, and aborting procedure.Customer reported a small amount of bloody drainage around collect pressure transducer.Customer also reported that tubing line from collect pressure dome to pump tubing organizer "seemed short" in length.The customer reported cleaning the fluids with out difficulty, and stated there was no visible fluid remaining after cleaning.Customer reports the estimated blood loss was a "small" amount, and physician on site gave orders for customer to reattempt patient's procedure on a different instrument.Customer reported physician did not order a transfusion or replacement fluids.Customer stated they were going to try a new kit on a different cellex instrument.Customer stated they would call back if they experienced any further issues.The customer returned the kit for investigation.There was no service order generated.

Manufacturer Narrative

The kit was returned for analysis.The pressure dome was tested for leaks and a leak was confirmed, as bubbles were visible from the joint between the collect pressure dome and the clear line to the pump tubing organizer (pto).Lack of solvent was also apparent on the bond, indicating a likely root cause of manufacturing operator error.As part of the corrective action, manufacturing operators were trained to reaffirm solvent bonding at this site.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4956364
• MDR Text Key: 24093973
• Report Number: 2523595-2015-00208
• 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: Other
• Report Date: 07/14/2015

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: 03/01/2017
• Device Lot Number: D312 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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 Weight: 50