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

Catalog Number 000000000000070629

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Incontinence (1928); Vomiting (2144); Complaint, Ill-Defined (2331); Loss of consciousness (2418); Sweating (2444)

Event Date 06/24/2014

Event Type  Injury  

Event Description

The customer reported that a patient had an anticoagulant (ac) reaction and had a vagal episode during a mononuclear cell (mnc) collection procedure.Approximately 40 minutes into the procedure, the patient complained of not feeling well, sick to the stomach, diaphoretic, and he then vomited.The rn paused the procedure and 100 ml of iv saline and crackers were given to patient in response to the reaction.Approximately 45 minutes after the ac reaction, the patient developed a vagal episode.The patient fell out, eyes rolled in the back of his head and became pulseless for about 15 seconds.After losing consciousness he became incontinent of urine and stool.Per physicians order, the rn kept airway patent (sternal chestrub), monitored vital signs, and a bolus of 300ml of normal saline was administered.The rn aborted and disconnected the patient and he was transferred to the hospital.Per the customer, the patient is stable, oriented, awake, and alert.The customer declined to provide patient's identifier.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to medical intervention via iv fluids during the procedure and hospitalization.

Manufacturer Narrative

Investigation: per the customer, the vagal nerve episode was in response to a bowel movement because the vagal nerve in the anus connected to the heart which caused an interruption in the heart's electricity.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the disposable set was unavailable for return and investigation.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A review of the lot for similar reports was carried out, none have been reported.Per the therapeutic apheresis handbook: a physician's reference, 2nd edition, first time procedure patients reactions may occur in approximately (b)(6) of procedures, and (b)(6) of procedure patients experience reactions to citrate, based on the results of a survey of therapeutic 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.(cobe spectra essentials guide)root cause: this disposable set was unavailable for specific root cause analysis.Based on information provided by the customer, it is possible that the patient exhibited an allergic reaction to acd-a and/or eto.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which anevent occurred, but the type of reportable event was not indicated appropriately in the mdr form.

• 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: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 3943906
• MDR Text Key: 4644334
• Report Number: 1722028-2014-00278
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2014

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 Expiration Date: 11/01/2014
• Device Catalogue Number: 000000000000070629
• Device Lot Number: 11U15281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2014
• Initial Date FDA Received: 07/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/10/2014; 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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
• Patient Age: 00084 YR
• Patient Weight: 77