MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923); Expulsion (2933)

Patient Problem Blood Loss (2597)

Event Date 02/01/2017

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 e359 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e359 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure and pressure dome membrane leak.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).Device not returned to manufacturer.

Event Description

The customer called to report an alarm #18: system pressure alarm and a system pressure dome membrane leak during a treatment procedure at approximately 200 mls of whole blood processed the customer reported that when the alarm #18: system pressure alarm occurred, the system pressure dome "popped off" of its transducer and a leak occurred.The customer stated that when they turned the pressure dome over to inspect its membrane, they found that part of the circular edge of the membrane had dislodged from the pressure dome.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient was in stable condition and that the patient's provider was notified of the leak.The customer reported that a 1000 ml normal saline fluid bolus was administered to the patient.The customer stated that the patient's estimated blood loss was approximately 200 mls.The customer reported that they drew a post cbc, but did not have the results back yet.In a follow up on february 02, 2017, the customer stated that the patient was in stable condition prior to, during, and after the leak.The customer reported that the patient has received standard ecp treatments routinely without difficulty.The customer stated that the patient was discharged after the aborted treatment in stable condition, and would be back in approximately four weeks to receive his next two ecp treatments.The customer confirmed that no blood products were ordered or administered to the patient in order to account for the patient's blood loss.The customer reported that the 1000 ml normal saline iv fluid bolus, was the only medical intervention that was ordered and administered to the patient.The customer stated that the patient's vital signs were stable during the saline bolus, after the saline bolus, and prior to discharge.The customer reported that no product would be returned for investigation.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: 6371393
• MDR Text Key: 69257614
• Report Number: 2523595-2017-00042
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E359(17)181001
• Combination Product (y/n): N
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/02/2017

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: 10/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E359
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 03/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2016
• 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: 9 YR
• Patient Weight: 28