MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Hole In Material (1293); Leak/Splash (1354); Device Displays Incorrect Message (2591); Pressure Problem (3012)

Patient Problem Blood Loss (2597)

Event Date 01/10/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e137 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e137 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #17: return pressure, alarm #45: red blood cell pump alarm, and pressure dome membrane leak.No trends were detected for these complaint categories.This case is reportable as a mdr due to the reportable malfunction of the pressure dome membrane leak.Since the pressure dome membrane leak is only associated with the kit, only one mdr will be filed for this case.This assessment is based on information available at the time of the investigation.At the time of this report, the analysis of the returned kit is still in progress.A supplemental report will be filed when the analysis of the kit is complete.(b)(4).

Event Description

The customer called to report a pressure dome membrane leak during a treatment procedure.The customer stated that at the start of the procedure there was an alarm #17: return pressure alarm which they were able to clear after flushing the return line.The customer reported that an alarm #45: red blood cell pump alarm occurred at about 991 ml of whole blood processed.The customer stated that they then noted that the interface was high so they opted to press stop and go to the purging air phase.The customer reported that during the purging air phase, they happened to glance down at the system pressure dome and saw a leak coming from the dome.The customer stated that they immediately closed off both the patient's collect and return lines and stopped the treatment.The customer reported that the treatment was aborted with no return of blood/products to the patient.The customer stated that the patient was in stable condition and no transfusion was required.The customer reported that when they removed the system pressure dome, they found that the pressure dome's membrane had a hole in it.The customer stated that there was only the one alarm #45: red blood cell pump alarm prior to the leak, and there were no other alarms throughout the treatment.The customer reported that there were no signs of any clotting or occlusions in the kit when it was removed.The kit was returned for investigation.

Manufacturer Narrative

The kit was returned for investigation.A visual examination of the kit confirmed the leak from the bottom of the system pressure dome.The system pressure dome had some dried blood on its latches and on other parts of its body.The pressure dome's membrane was also found to be partially unseated.No obvious defects in the body of the system pressure dome were seen during the examination.The pressure dome's membrane was pushed back into place onto the pressure dome's body and the pressure dome was installed on a pressure sensor in the lab in order to check its fit.There were no issues installing the pressure dome and its latches fit into the circumferential groove around the pressure sensor as expected.The pressure dome was then pressure tested in order to check for leaks, and no leaks were found.Thus testing did not find any evidence that there was an issue with the system pressure dome that could have caused or contributed to the leak.The most likely cause for the leak was an operator installation issue with the system pressure dome.An operator installation issue with a pressure dome can result in the unseating of the pressure dome's membrane.If one of the latches of the pressure dome is not fully secured into the circumferential groove around the sensor, there could be enough space below the membrane to allow it to move away from the body of the pressure dome if the pressure in the line becomes great enough.A leak can occur when any part of the pressure dome's membrane is not fully seated.The occurrence of the alarm #45: red blood cell pump alarm and the alarm #17: return pressure alarm could not be confirmed based on the information provided, nor could it be determined if there was an issue with the kit that could have caused or contributed to these alarms.A device history review did not find any related nonconformances and this kit lot had passed all lot release testing.No further action required.This investigation is now complete.(b)(4).

• 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 ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6308714
• MDR Text Key: 67217465
• Report Number: 2523595-2017-00027
• 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: 02/06/2017

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: 09/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2017
• Initial Date FDA Received: 02/07/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• 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: 68 YR
• Patient Weight: 91