MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA WBC SET, CLOSED

Model Number 950000000

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591); Reset Problem (3019)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2016

Event Type  Injury  

Manufacturer Narrative

Investigation: the machine was checked out by a terumo bct technician.The alarm failure was verified and the arm assembly was replaced.A saline run was successfully completed and the machine was returned to service.Investigation is in process.A follow-up report will be provided.

Event Description

While trouble shooting an alarm with the terumo bct clinical specialist, the operator started to see air in the return line.The customer had been halfway through the procedure when she received an alarm and was not able to continue.The clinical specialist was talking the operator through manual rinse back after not being able to restart the procedure during troubleshooting when the operator noted the air.When the air was seen, the operator clamped the line and the air did not get to the patient.Rinse back was not completed for this patient.No medical intervention or patient follow-up was required for this event.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer estimated the size of the air bubble to be approximately 0.25" in length in the tubing.The customer also stated that the line was clamped before any air could reached the patient.The calculated volume of air that was at risk of reaching the patient was 0.0002705ml/kg.Per consultation with terumo bct's engineer, the air seen in the return line has no relationship to the alarm that the customer received.The operator's manual provides instructions for manual rinse back and states "warning: the spectra system alarm system is inactive during manual rinse back.If you must perform a manual rinse back, watch for air in the return line when returning blood to the donor or patient.If you see air, immediately discontinue the rinse back." root cause: root cause of the air in the set is undetermined.Possible causes for an air block include but are not limited to: loading issue resulting in an airblock.Manipulation of patient access.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA WBC SET, CLOSED
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5525236
• MDR Text Key: 41139734
• Report Number: 1722028-2016-00145
• 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
• Report Date: 03/24/2016

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 Model Number: 950000000
• Device Catalogue Number: 70620
• Device Lot Number: 01Z15287
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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 Outcome(s): Other
• Patient Age: 00039 YR
• Patient Weight: 152