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

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Detachment of Device or Device Component (2907)

Patient Problem Blood Loss (2597)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 g356 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g356 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned kit and photograph is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated the tubing from the pump tubing organizer (pto) separated from the hematocrit sensor resulting in a leak of saline and anticoagulant.The customer stated approximately 1355 ml of whole blood was processed at the time of the tubing leak.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned the kit and a photograph for investigation.

Manufacturer Narrative

The complaint kit, smartcard, and photographs were returned for investigation.A review of the data recorded on the returned smartcard shows prime was completed and blood collection had started.The treatment proceeded until the operator aborted the treatment after 1355 ml of whole blood was processed.The customer provided photograph shows the treatment bag inlet tubing is no longer attached to the hct cuvette.The returned kit was examined and confirmed the tubing leak as the inlet tubing was not attached to the cuvette as shown in the photograph.The detached tubing was examined and the solvent mark on the tube verifies that the tube was fully inserted into the cuvette.The remaining solvent on the tubing indicates that the tube was dipped into solvent at an angle during manufacturing and not straight down per work instruction.The investigation determined the root cause of the tubing leak was most likely manufacturing operator error due to insufficient solvent during the tube bonding process.Retraining has been completed for manufacturing operators who perform this operation.No further action is required at this time.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8214634
• MDR Text Key: 132592975
• Report Number: 2523595-2019-00001
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G356(17)200801
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

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: 08/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2018
• Initial Date Manufacturer Received: 12/04/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 01/04/2019
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 71