MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 10/18/2017

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 pto 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 f306 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f306 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, pto leak.No trends were detected for this complaint category.A photo analysis was conducted for this complaint.A review of the photo could not confirm the reported leak.The photo was a close up view of the pto which showed the tubing sections within the pto.The evaluation of the photo determined that there were three different tubing sections within the pto that appeared to contain blood.The review also found that there was blood within the y connector that connects the plasma tubing.However, the investigation could not determine if the blood within the y connector was inside the plasma tubing, in the joint between the plasma tubing and the y connector, or on the outside of the y connector.The photo evaluation found no evidence of a leak within or on the pto.The reported pto leak could not be verified thus no root cause could be determined for this case.The device history record review did not result in any related nonconformances and this lot had passed all lot release testing.The assessment is based on information available at the time of the investigation.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.

Event Description

The customer called to report a pump tubing organizer (pto) leak that occurred during a treatment procedure.The customer stated that the purging air phase of the treatment was successfully completed.However, the customer reported that during the collect/return phases of the treatment they noticed a leak under the pto.The customer stated that there were no alarms during the treatment.The customer reported that the leak occurred very early in the treatment at around 200ml of whole blood processed.The customer stated that the treatment was aborted with no return of blood/products to the patient.The customer reported that the patient was in stable condition and that they did not consider this a serious event.A photo was submitted for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7039783
• MDR Text Key: 93472362
• Report Number: 2523595-2017-00203
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F306(17)190201
• 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: 11/16/2017

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: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2017
• 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