MAUDE Adverse Event Report: THERAKOS, INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Blood Loss (2597)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction clot observed.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 f351 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot f351 for the reported issue shows no trends.Trends were reviewed for complaint categories, clot observed and alarm #17: return pressure.No trends were detected for each complaint category.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 photograph is still in progress, the smartcard has not yet been received.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report clots observed in the centrifuge bowl and return line during the treatment procedure.The customer received an alarm #17: return pressure alarm at approximately 250 ml of whole blood processed.The customer ran a saline bolus into a bin where clots were observed in the return line.The customer stated there was also clotting in the centrifuge bowl.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and no clots made it to the patient.The customer has returned a photograph and will be returning the smartcard data for investigation.

Manufacturer Narrative

A photographic analysis was conducted for this complaint.The customer indicated that the smart card would not be returned for evaluation; therefore, the alarm #17: return pressure alarm could not be verified.As a result, a root cause for the alarm could not be determined based on the information provided.The customer provided photograph confirms the reported clotting in the centrifuge bowl.There were no photographs provided of the return line; therefore, the reported clotting in the return line could not be confirmed.The root cause for this occurrence could not be determined based on the complaint description and provided photograph.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.04/12/2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7386540
• MDR Text Key: 104271198
• Report Number: 2523595-2018-00051
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F351(17)190901
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2018

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: 09/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F351
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/30/2018
• Supplement Dates Manufacturer Received: 04/11/2018
• Supplement Dates FDA Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR