MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Air Leak (1008); Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 06/16/2017

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 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 of kit lot f217 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f217 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure, pressure dome membrane leak, and equipment performance.No trends were detected for these complaint categories.The assessment is based on information available at the time of the 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.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).

Event Description

The customer called to report a pressure dome membrane leak.The customer stated that an alarm #18: system pressure alarm occurred at approximately 1400ml of whole blood processed.The customer reported that they did not notice any air going into the bowl.The customer stated that as the bowl stopped, they noticed that the return bag was empty and that the air filter was filled with air.The customer reported that no air had gone into the return line so there was no alarm.The customer stated that they selected to end the treatment, but the bowl did not fully empty.The customer reported that prior to returning the blood to the patient, they clamped the patient's line and attempted to flush the return line in order to fill the air filter with saline.The customer stated that this then caused the return pressure dome to pop off its sensor and leak.The customer reported that the treatment was then aborted with no return of blood/products to the patient.The customer stated that the patient's volume loss was approximately 140 ml, which was the content of the bowl.The customer reported that no clots were observed.The customer stated that the patient was in stable condition and no medical intervention was required.The kit was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6704842
• MDR Text Key: 79964518
• Report Number: 2523595-2017-00126
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 07/11/2017

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: 03/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/16/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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: 43 YR
• Patient Weight: 72