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

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 04/05/2017

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 alarm #7: blood leak (centrifuge chamber).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 d343 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot d343 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, alarm #7: blood leak (centrifuge chamber).No trends were detected for this complaint category.The assessment is based on the 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.Investigation complete.Mc: 019037 p.T.(b)(6) 2017.Device not returned.

Event Description

Customer called to report alarm #7: blood leak (centrifuge chamber) that occurred during treatment.The operator used a white towel to gently blot along the leak detector strip to verify if any liquid had leaked onto the detector strip, the operator stated there appears to be a fine spray of blood that has leaked from the kit.The operator could not visually determine the source of the leak.The operator aborted the procedure without return of blood to the patient.Customer stated patient is stable, and no intervention was required.Customer will not be returning product for investigation.

• 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 ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6541659
• MDR Text Key: 74512720
• Report Number: 2523595-2017-00073
• 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
• Report Date: 05/03/2017

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: 07/01/2017
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: D343
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2015
• 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 Age: 47 YR
• Patient Weight: 67