MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/14/2017

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.Kit lot f307 was reviewed.There were no non-conformances.This lot met all release requirements.A review of kit lot f307 shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure, pressure dome membrane leak.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 kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report an alarm #18: system pressure followed by a blood leak at the system pressure dome.The customer stated that the instrument primed successfully without any error.The system pressure leak was said to have occurred at about 13 minutes into the treatment; 218 mls whole blood processed.The treatment was aborted with no blood return and the patient was quickly clamped off of the procedure.The patient was in stable condition and was not affected by the incident.The kit will be returned for investigation.

Manufacturer Narrative

The complaint kit was returned for analysis.Evaluation of the returned kit identified that the diaphragm of the system pressure dome was missing.Further evaluation of the returned kit determined the pattern of dried blood exhibited on the body of the system pressure dome is consistent with a leak due to a partially displaced diaphragm; not a missing diaphragm.If the latches of the pressure dome are not fully secured in the circumferential groove around the sensor, the diaphragm can move and become partially unseated if the pressure increases.Pressure domes are leak tested three separate times during manufacturing; therefore, a missing or partially unseated pressure dome diaphragm would have been identified prior to release.No kinked tubing or obvious defects which could have contributed to a system pressure alarm were identified upon inspection.No blood solids or leaks were observed upon evaluation of the returned kit's centrifuge bowl.No manufacturing related defects were confirmed during the evaluation.The root cause of the reported pressure dome membrane leak was likely due to improper installation of the pressure dome onto the instrument's system pressure sensor.The reported system pressure alarm could not be verified as the kit's smart card was not returned for evaluation.Furthermore, evaluation of the returned kit did not identify any issues which could have contributed to the occurrence of a system pressure alarm.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: 6861245
• MDR Text Key: 87309354
• Report Number: 2523595-2017-00168
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F307(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,Followup
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2017
• 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: F307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2017
• 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
• Patient Age: 17 YR