MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/04/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunctions of the drive tube leak/break and centrifuge bowl leak/break.Since these reportable malfunctions are only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f126 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f126 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break, alarm #7: blood leak (centrifuge chamber), drive tube leak/break, and noise.No trends were detected for these complaint categories.A photo analysis was conducted for this complaint.A review of the photos confirmed the leak, as the photos indicated that there was a leak within the centrifuge chamber.The evaluation of the photos determined that the centrifuge bowl had broken and that the centrifuge bowl's cover was still locked into the instrument's platen.The photos also showed that the drive tube had broken in half and that the centrifuge leak detector strip was damaged.The alarm # 7: blood leak (centrifuge chamber) alarm, damaged centrifuge leak detector strip, and the drive tube leak/break are all most likely a result of the centrifuge bowl breaking at high speed.However, the root cause for the centrifuge bowl leak/break could not be determined based on the information provided.The device history record review did not result in any related nonconformances and this kit lot had passed all lot release testing.A material trace of the centrifuge bowl assembly and its components used to build this kit lot also found no related nonconformances.No further actions required.This investigation is now complete.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.(b)(4).

Event Description

The customer called to report a centrifuge bowl leak/break, drive tube leak/break, alarm #7: blood leak (centrifuge chamber) alarm, and noise that occurred during a treatment procedure.The customer stated that at about twenty five minutes into the treatment, there was a loud banging noise and then a leak was noticed within the centrifuge chamber.The customer reported that there was no obvious button to press on the instrument's screen so they immediately turned off the instrument.The customer stated that this all happened very quickly but they did notice a fluid leak message on the instrument's screen when they turned off the instrument.The customer reported that there had been no other alarms up to that point.The customer stated that the treatment was aborted with no return of blood/products to the patient.The customer reported that the volume that remained within the kit was around 200 to 300 ml.The customer stated that the patient was in stable condition and was not impacted by the incident.The customer reported that the patient was treated on another instrument.The customer stated that the centrifuge bowl was in many pieces and the drive tube was "sheared" into more than one piece.The customer reported that the very bottom of the centrifuge bowl was still in place.The customer stated that they remembered doing their usual check in order to ensure that the drive tube was correctly installed in both the upper and lower bearings retainer clips of the centrifuge frame.The customer reported that this check involved both a visual inspection and the swinging of the centrifuge frame.Photos were 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: 6992023
• MDR Text Key: 91528697
• Report Number: 2523595-2017-00194
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 10/31/2017

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: 07/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2017
• 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