MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA CLOSED WHITE BLOOD CELL COLLECT SET

Catalog Number 70629

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Nausea (1970); Tingling (2171)

Event Date 07/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Lot number, expiry and manufacture date are not available at this time.Investigation: in the journal, it stated that the majority of the patients' were male, carrieda diagnosis of acute lymphoblastic leukemia and weighed more than 25 kg and the apheresis complications did not correlate with patient's with younger age or lower weight.The lymphapheresis procedure was performed on a cobe spectra device by experienced apheresis nurses collecting at a hematocrit of 2% to 3% and a collection flow rate of 1.0ml/min.Patients under 18 years old all had central venous catheters (cvcs) placed before the procedure by an experienced vascular access team; those more than 18 years old were assessed to determine whether their peripheral veins were adequate or whether a cvc was needed.During the procedure, the patient received intravenous calcium chloride, prepared and infused according to standard procedures.Patients weighing less than 40 kg also received intravenous magnesium sulfate.The cobe spectra disposable set was primed with 1 unit of irradiated, leukoreduced rbcs for all patients weighing less than 20 kg from july 2012 through january 2014 and subsequently for all patients weighing less than 25 kg, due to a change in institution practice.If the patient experienced symptoms of hypocalcemia during the procedure, the calcium infusion rate was increased by 10% to 20%.Pre and post-procedure, a complete blood count was performed using a hematology analyzer.Investigation is in process.A follow-up report will be provided.Journal citation:allen, e.S., stroncek, d.F., ren, j., eder, a.F., west, k.A., fry, t.J., ¿ conry-cantilena, c.(2016).Autologous lymphapheresis for the production of chimeric antigen receptor t cells.Transfusion, 00, 2-9.Doi:10.1111/trf.14003.

Event Description

During a terumo bct review of the transfusion journal, a report was found of 10 patients experiencing reactions during a lymphapheresis procedures on a cobe spectra device.During the procedures, the patients experienced tingling, nausea, headaches, bleeding, and musculoskeletal pain.According to the article, these complications were managed in the apheresis clinic, including all parasthesias, after adjusting the calcium infusion rate.Patient information and outcome are not available at this time.The cobe spectra collection set is not available for return because it was discarded by the customer.The date of the procedures are not known at this time.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Follow-up with the customer has clarified that the medical intervention reported in the journal article was part of their standard operating procedure.No further medical intervention was reported.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, overall patient reactions may occur in approximately 4.8% of procedures.Of these reactions, most were mild and well tolerated.According to the cobe spectra essential's guide, the cobe spectra system has many safety features.A donor and/or patient reaction can occur rapidly, however.It is imperative that the operator continuously monitor the cobe spectra system and the donor and/or patient.Root cause: a definitive root cause was not determined.It is possible that the reaction was the result of the patients experiencing eto allergies or acda reactions.

Event Description

Follow-up with the journal article author clarified the medical intervention given to 10 patients was part of their standard operating procedures and no further medical intervention was reported.Additionally, 1 patient reaction that required medical intervention is reported in mdr#: 1722028-2017-00098.The journal article author provided the study participant¿s age, gender, weight, and procedural dates.However, due to hippa regulations, the author could not provide the study participant¿s identifier and specific procedural details and lot information.Therefore, it cannot be determined of which specific study participant required the medical intervention.(b)(6).

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA CLOSED WHITE BLOOD CELL COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 6438801
• MDR Text Key: 71039531
• Report Number: 1722028-2017-00090
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK020041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 70629
• Other Device ID Number: 05020583706293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Weight: 83