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

Catalog Number 70600

Device Problems Device Alarm System (1012); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 01/12/2016

Event Type  Death  

Manufacturer Narrative

Investigation: the machine that was involved in this incident was checked out by a terumo bct technician.A full saline run was completed successfully and the machine performed according to manufacturing specifications.Autopsy results are pending.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported an operator was getting centrifuge pressure high alarms, that they were unable to clear during a white blood cell depletion procedure.The procedure ran for twenty minutes, then it was aborted.No medical intervention was necessary at the time, and the procedure was not restarted on another set or machine.The patient, who was already an inpatient, passed away the next morning.The customer stated that the patient was not connected to the machine at the time of death.The patient identifier is not available per the customer.The disposable kit is not available for return, because it was discarded by the customer.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Terumo bct's medical review determined that due to the limited information available it is not possible to assess the involvement of the cobe spectra in the patient's death.There is no evidence that points to the device having caused or contributed to the patient's death.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer declined to release the autopsy report.Based on terumo bct's internal the risk assessment, there is not a clear agreement within the medical community on the role of leukapheresis in decreasing mortality due to leukemia with hyperleukocytosis, however, alternative supportive procedures have been recommended in childhood a.L.L.And are usually used even when leukapheresis is done.Based on the limited information available there is no evidence indicating that the cobe spectra caused or contributed to the patient¿s death.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes and additional mfr narrative.Root cause: a definitive root cause for the patient¿s death could not be determined.The customer stated that the patient was not attached to the machine at the time of death.The machine was inspected and found to be in proper working order.The patient was already an inpatient with a.L.L.Per the terumo bct medical monitor¿s review, there is no evidence that indicates cobe spectra caused or contributed to the patient¿s death.Causes of the centrifuge pressure high alarm can be related to restriction of the blood flow (kinks, clamps, poor venipuncture, etc.), too high of an inlet flow rate, or stopping the centrifuge multiple times during the procedure.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WHITE BLOOD CELL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5415031
• MDR Text Key: 38652812
• Report Number: 1722028-2016-00075
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/05/2016

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: 12/01/2017
• Device Catalogue Number: 70600
• Device Lot Number: 12Y15254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2016
• Initial Date FDA Received: 02/06/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/24/2016; 10/07/2016; 11/18/2016; 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2015
• 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): Other
• Patient Age: 00004 YR
• Patient Weight: 20