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

Model Number NOT APPLICABLE

Device Problem Device Alarm System (1012)

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

Event Date 10/30/2019

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 in the return line.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 h131 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h131 for the reported issue shows no trends.Trends were reviewed for complaint categories, clot observed, alarm #17: return pressure, and alarm #53: return line air detected.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 returned smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report blood clots were observed in the return line of their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported at approximately 650 ml of whole blood processed they received an alarm #17: return pressure alarm and alarm #53: return line air detected alarm.The customer attempted to wash the patient access and run a saline bolus through the return line; however, the customer was unable to resolve the alarm #17 and alarm #53.At 660 ml of whole blood processed the physician decided to end the treatment and manually return the residual blood within the kit to the patient.The customer reported after the patient was disconnected they observed clots in the return line.The customer stated the patient was stable and started a new treatment that was successfully completed.The customer discarded the kit; however, has returned the smart card for evaluation.

Manufacturer Narrative

The smart card data was returned for evaluation.A review of the data recorded on the smart card verified prime was completed and blood collection started in double needle mode.The smart card data showed several alarm #16: collect pressure alarms occurred after 626 ml of whole blood was processed.Following the collect pressure alarms many alarm #17: return pressure alarms were received.Also several alarm #53: return line air detected alarms occurred after 646 ml whole blood processed.The reported clotting observed in the return line could not be verified based on the smart card data.The root cause for the alarm #17 return pressure alarms and alarm #53: return line air detected alarms was most likely due to clotting in the return line.The customer reported the patient often has issues with clotting during treatments.Section 2-8 of the cellex operator's manual (1470069 rev5.0) on anticoagulant states "caution: individual patients may require a heparin dosage that varies from the recommended dose to prevent post-treatment bleeding or clotting during a treatment.The physician should review the patient's medical condition, medications and platelet count at the time of treatment and use clinical judgment to establish the optimal heparin dosage for each patient." the root cause for the clotting observed could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.10-jan-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9390388
• MDR Text Key: 196090636
• Report Number: 2523595-2019-00142
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

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: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H131
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/28/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1