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

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Output Problem (3005)

Patient Problem Blood Loss (2597)

Event Date 09/06/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane leak.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 g338 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g338 for the reported issue shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak and system error 3.No trends were detected for each complaint category.The assessment is based on the information available at the time of investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Review of the customer's complaint description identified that the customer had removed or manipulated the system pressure dome during the treatment.Section 4-16 of the therakos¿ cellex¿ photopheresis system operator's manual states "do not remove any pressure dome during a treatment".Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation complete.(b)(4).

Event Description

The customer called to report a pressure dome membrane leak during the treatment procedure.The customer stated they received a system pressure alarm that was reset and the procedure was resumed.The customer stated they received a system error 3 alarm and powered the instrument off and on to clear the alarm.The customer stated they removed the pressure dome to check if it was loaded correctly and resulted in a blood leak.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer will not be returning the product.

• 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: 7939950
• MDR Text Key: 124130597
• Report Number: 2523595-2018-00153
• Device Sequence Number: 0
• Product Code: LNR
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2018
• Initial Date FDA Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 0