MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Defective Alarm (1014); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot e369 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e369 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.The assessment is based on information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned.

Event Description

Customer called to report the collect pump tubing segment began leaking at approximately 191 mls of whole blood processed.Customer immediately stopped the centrifuge bowl, disconnected the patient, aborted the procedure, and did not return fluids to the patient.Customer said there were no prior alarms to the leak.Customer mentioned when loading the collect pump tubing segment, that it was "tighter" than usual, and that it kinked up on one side when initially loading the segment.Customer said the tubing kink went away after rotating the pump in the opposite direction, but customer stated she thought that there may have been some trauma to the collect pump tubing segment during loading that may have caused the leak.Customer said there was blood underneath the pump tube organizer near the collect pump tubing segment, and said that blood had leaked underneath the collect pump head.Customer said the patient was stable, and would not need any medical intervention, fluid bolus, or blood transfusion.Customer also mentioned they started a new treatment on a different instrument with this patient, and that he was tolerating the therapy well with no issues.

• 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: 6439842
• MDR Text Key: 71408073
• Report Number: 2523595-2017-00055
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E369(17)181101
• 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
• Report Date: 03/28/2017

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: 11/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E369
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2016
• 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: 21 YR
• Patient Weight: 62