MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Break (1069); Leak/Splash (1354); Noise, Audible (3273)

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

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the centrifuge bowl leak/break.Since these reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot f101 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot f101 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, centrifuge bowl leak/break, noise.No trends were detected for these complaint categories.The customer photographs were returned for investigation.The analysis of the customer photographs and complaint description verify the reported centrifuge bowl leak/break.A material trace of the bowl assembly and its components used to build kit lot f101 found no related nonconformance's.This lot passed lot release testing's.The root cause for the reported centrifuge bowl break could not be determined.No further action is required at this time.Investigation complete.(b)(4).

Event Description

The customer reported a centrifuge bowl leak break that occurred during treatment.The customer explained that at the point of buffy coat collection, the bowl was spinning as it should and then suddenly a noise was heard that came from the kit inside the centrifuge chamber.The bowl break was seen at approximately 150ml of blood.The machine was then turned off, the patient lines were clamped and the treatment was then ended.The patient was in stable condition and not impacted by the incident.The customer has returned photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; 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: 7040673
• MDR Text Key: 93440592
• Report Number: 2523595-2017-00207
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 11/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2017
• 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
• Patient Age: 57 YR