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

Catalog Number 000000000000070500

Device Problem Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Decreased Respiratory Rate (2485)

Event Date 03/19/2014

Event Type  Death  

Event Description

The customer reported that after a therapeutic plasma exchange (tpe) procedure was completed and the patient was removed from the machine, the patient began complaining of stomach pain.The patient's vital signs were unchanged, but suddenly the patient became very short of breath with a respiratory rate in the 40s.The apheresis nurse called for the micu nurse.By the time the nurse came in, the patient became unresponsive and the nurse called a code.The code team intubated the patient and tried for 2 hours to get a stable pulse.They were unable to revive the patient.The disposable set is unavailable for return because the customer discarded it.This report is being filed due to patient death, though at this time, it is not suspected or alleged that the device caused or contributed to the death.

Manufacturer Narrative

Investigation: per the customer, approximately 45 minutes from the end of the procedure,the patient received a suppository from the micu nurse.A full functional check out of the machine was performed at the customer site.Voltages, pressure sensors, rbc detector, valves operation were all verified.A simulated saline run was completed successfully.The unit met all manufacturing specs.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

(b)(4).Investigation: the autopsy report was requested but is not available.A review of the device history record (dhr) for this lot 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.Root cause: this disposable set was unavailable for specific root cause analysis.A definitive root cause could not be determined.Possible causes for the patient death include but are not limited to patient physiology and/or patient disease state.

Manufacturer Narrative

This report is being filed to provide additional information.Additional information: according to "therapeutic apheresis: a physician's handbook," the rate of adverse events during therapeutic apheresis is 4%-5%.Morbidity and mortality related to therapeutic procedures are greater in acutely ill patients treated in a hospital setting.A patient's death during an apheresis series is most often attributed to the underlying disease and is rarely directly related to the procedure (sqs attachment).The cobe spectra apheresis system essentials guide outlines the following warnings and cautions:-"warning: when using biologically-derived replacement fluids, closely monitor the patient for reactions."-"caution: 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 continued: the evidence from this investigation indicates that the device did not cause or contribute to the patient death.Service check did not show any issues with the machine.Literature review also indicates that a patient's death during an apheresis series is most often attributed to the underlying disease and is rarely directly related to the procedure.

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.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA TPE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: kristen cohen ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 3759347
• MDR Text Key: 4553126
• Report Number: 1722028-2014-00127
• 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,Followup
• Report Date: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2016
• Device Catalogue Number: 000000000000070500
• Device Lot Number: 12V15243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/16/2014; 03/28/2016; 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00054 YR
• Patient Weight: 88