MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Swelling (2091); Dizziness (2194); Malaise (2359); No Information (3190)

Event Date 06/19/2017

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the medical intervention of the benadryl that was given to the patient.Since the customer suggested that this event might be associated with the gas, ethylene oxide, used to sterilize the kits, this mdr will be against the kit.A batch record review of kit lot d153 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot d153 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories, nausea, swelling, malaise, dizziness, and face/neck flushing.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.Adverse event terms: nausea; swelling; malaise; dizziness; and other: face/neck flushing.(b)(4).

Event Description

The customer called to report that a patient developed peri-orbital swelling, nausea, face flushing, malaise and dizziness at approximately 373 ml of whole blood processed during a double needle mode treatment.The customer stated that they stopped the procedure at the onset of the patient's symptoms, and allowed the symptoms to resolve on their own without any medical intervention.The customer reported that the symptoms took approximately 10 to 20 minutes to resolve.The customer stated that they then restarted the treatment, however the symptoms returned.The customer reported that they stopped the treatment again and the patient's symptoms resolved on their own.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient's vital signs were stable before, during, and after the onset of the symptoms.The customer stated that the treating physician had ordered oral benadryl for the patient's symptoms.The customer reported that the patient's symptoms were all resolved by the time the patient was discharged.The customer stated that acda was used as the anticoagulant for this treatment, with an anticoagulant ratio of 10:1.The customer reported that the patient's central venous access was "packed" with "high dose" heparin; and that the patient was pre-medicated with "tums".The customer stated that they thought the patient's symptoms were either caused by a citrate reaction due to the acda anticoagulant or an ethylene oxide reaction ethylene oxide is used to sterilize the kits.The customer reported that the patient had already successfully completed 49 treatments prior to this event, and they were not sure what may have caused the patient's symptoms.The customer stated that the patient was discharged home in stable condition and would return to the clinic the following day, (b)(6) 2017, for a re-attempt at the treatment.The customer reported that the treating physician ordered a pre-ionized calcium lab draw, and a continuous iv calcium replacement for the next treatment.The customer stated that on the following day the patient's pre-treatment ionized calcium lab value came back "normal," and that the patient's pre-treatment assessment was also "normal" with no left over symptoms from the day before.The customer reported that the treating physician based on the patient's calcium lab results then changed the iv calcium order to only initiate if the patient started to have symptoms during the procedure.The customer stated that the second treatment was completed without any issues, and that the patient tolerated the procedure well.The customer reported that no iv calcium was administered during this procedure.The customer stated that they were still unsure what caused the patient's symptoms during the previous treatment.The customer reported that they still thought that the symptoms were either due to a citrate reaction or an ethylene oxide reaction.The customer stated that the only difference between the two treatments was when the "tums" were administered to the patient.The customer stated that during the previous treatment, they administered the patient's "tums" a little later than they normal do." the customer stated that for the second treatment, they administered the patient's "tums" at their "normal pre-procedure time." 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: 6723814
• MDR Text Key: 80383827
• Report Number: 2523595-2017-00124
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 12/01/2017
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: D153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 75