MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Air Leak (1008)

Patient Problem No Code Available (3191)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot f118 was conducted.There were no non-conformances related to this complaint.This lot met all release requirements.A review of kit lot f118 for the reported issue shows no trends.Trends were reviewed for complaint category pressure dome membrane leak.No trend was 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.(b)(4).

Event Description

The customer called to report a system pressure dome membrane leak that occurred during a patient treatment.The leak occurred after purging air, there was about 150mls of whole blood processed.The treatment was aborted and no blood was returned back to the patient.The customer stated that the patient was in stable condition and not affected from the incident.

Manufacturer Narrative

Evaluation of the customer returned system pressure dome and smartcard has been performed.Visual inspection of the customer returned system pressure dome verified that a leak had occurred during treatment.The pressure dome diaphragm was observed to be partially unseated and dried blood was present on the pressure dome latches.No molding defects were identified upon inspection of the pressure dome body.The customer returned system pressure dome was cleaned, reassembled, installed onto a pressure transducer and pressure tested.No leaks were observed upon completion of the testing.Review of the customer return smartcard determined an alarm #18: system pressure had occurred due to high pressure detected at the system pressure dome just before the customer aborted the treatment.As a result, the investigation determined that the probable root cause for the pressure dome membrane leak was improper installation of the system pressure dome.The pressure dome's membrane can become partially unseated when exposed to high pressure if one of the pressure dome latches is not fully secured onto the circumferential groove around the pressure transducer.No issues were noted upon review of the device history record and complaint trending.Furthermore, no manufacturing defects were identified during evaluation of the returned product.No further action required at this time.Investigation complete.Investigation complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; 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: 7137389
• MDR Text Key: 96126005
• Report Number: 2523595-2017-00232
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/29/2018

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: 04/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2017
• 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