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

Catalog Number CLXECP

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem Blood Loss (2597)

Event Date 10/01/2020

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 j215 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j215 shows no trends.Trends were reviewed for complaint categories, clot observed, alarm #16: collect pressure, alarm #17: return pressure and alarm #18: system pressure.No trends were detected for these complaint categories.The customer returned photographs and the smart card data for evaluation.A review of the data recorded on the returned smart card verified the occurrence of multiple alarm #16: collect pressure and alarm #17: return pressure alarms for pressure below the lower limit.There was also multiple alarm #18: system pressure alarms for pressure above the upper limit.The reported alarms are consistent with obstructions to flow in the kit such as clots.A review of the provided photographs verify clotting in the return bag as reported by the customer.The reported clotting in the return line could not be verified based on the photographs provided.Section 2-8 of the cellex operators manual (1470068 rev.C) 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 judgement 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.Comp (b)(4).Pt (b)(6) 2020.

Event Description

The customer contacted mallinckrodt to report they experienced clots observed in the return line with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis treatment.The customer reported they received an alarm #16: collect pressure alarm that was resolved and the procedure continued.The customer reported after approximately 1400 ml whole blood processed they received an alarm #17: return pressure and alarm #18: system pressure.The customer reported they observed a blood clot in the return bag and clotting in the return line.The physician decided to abort the ecp treatment without returning residual blood within the kit to the patient.The customer stated the patient was in stable condition.The customer returned photographs and the smart card data for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 10752308
• MDR Text Key: 249643300
• Report Number: 2523595-2020-00115
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/28/2020

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: 03/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: J215
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: 70