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

Catalog Number 70629

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fever (1858); Nausea (1970); Vomiting (2144)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Lot number, expiry and manufacture date are not available at this time.Investigation: in the journal, it stated that apheresis complications did not correlate with the patient¿s younger age or lower weight.The patient showed no signs of hypocalcemia during or immediately after the procedure, and his complications were thought to be related to his underlying disease rather than apheresis.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 1.0 ml/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.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 a patient receiving medical intervention for a reaction during a during a lymphapheresis procedures on a cobe spectra device.During the procedure, the patient developed fever, nausea, vomiting, hallucinations, seizures and oxygen desaturation to 87% and clotting was noticed in the patient's tubing line.The procedure was ended early and the patient was intubated, given supplemental oxygen and transferred to the icu for 19 days before being returned to a lower level of care.Patient id, age and weight are not available at this time.Patient outcome is not available at this time.The collection set is not available for return because it was discarded by the customer.The date of the procedure is not known at this time.The date of the article has been provided in date of event.

Manufacturer Narrative

This report is being filed to provide additional information.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.The procedure was associated with a clinical study with patients participating in collections that were performed on the cobe spectra.Per information provide in the journal article, the patient complications were thought to be related to his underlying disease state rather than the apheresis.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.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 patient physiology, based on information provided in the article.

Manufacturer Narrative

This report is being filed to provide additional information in describe event or problem and initial reporter.

Event Description

Follow-up with the journal article author clarified that 1 out of the 11 patient was given medical intervention during a lymphapheresis procedures on a cobe spectra device.Additionally, the medical intervention given to 10 patients were given per standard operating procedure and no further medical intervention were reported in mdr#: 1722028-2017-00088, 1722028-2017-00089, 1722028-2017-00090, 1722028-2017-00091, 1722028-2017-00092, 1722028-2017-00093, 1722028-2017-00094, 1722028-2017-00095, 1722028-2017-00096, and 1722028-2017-00097.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, procedural details and lot information.Therefore, it cannot be determine which specific study participant required the medical intervention.The following study participant¿s age, gender, weight and procedural dates were provided: (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: 6438824
• MDR Text Key: 71039947
• Report Number: 1722028-2017-00098
• 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,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; Not provided
• Supplement Dates FDA Received: 05/12/2017; 06/05/2017
• 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): Hospitalization; Required Intervention