MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2017

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 e146 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot e146 for the reported issue shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak, noise.No trends were detected for these complaint categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the customer provided photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer contacted the distributor to report a pressure dome membrane leak.The customer stated that the priming and installation of the kit was completed successfully.The patient was connected and during the air extraction phase, the patient's venous access flow was not adequate.The operator of the device stopped the procedure to try to find another venous access.After the machine had been stopped for approximately 40 minutes, the pressure of extraction sensor was released.The customer stated that a noise was heard and blood came out of the cassette.The patient was not connected to the kit when the leak occurred.The treatment was ended and the kit was discarded.The patient was reported to have been in stable condition and was not affected by the incident.The customer provided photographs for investigation.

Manufacturer Narrative

The customer provided photographs were returned for investigation.The photographs verified the customer reported pressure dome membrane leak.The customer photographs show that the return pressure dome housing is detached from the instrument's pressure transducer, and the return pressure dome's diaphragm is lying on the instrument's pump deck.Pressure domes are leak tested twice at the sub-assembly level and once during finished product testing to detect manufacturing related failures.A material trace of the pressure dome housing assembly and the components used to build kit lot e146 did not identify any non-conformances.A root cause for the reported pressure dome membrane leak could not be determined based on the customer's complaint description, batch record review, complaint trending and customer provided photographs.No further action required at this time.Investigation complete.Investigation complete.(b)(4).A.B: (b)(6) 2018.

• 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: 7165927
• MDR Text Key: 97638644
• Report Number: 2523595-2018-00001
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 12/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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: 55 YR