MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA BLOOD COLLECTION; COBE SPECTRA APHERESIS SYSTEM

Model Number 000000000950000000

Device Problem Improper Flow or Infusion (2954)

Patient Problems Overdose (1988); Anxiety (2328)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

Terumo bct received a medwatch form in which the customer reported that a patient received a bolus of anticoagulant (ac) during a therapeutic plasma exchange (tpe) procedure.During the rinseback portion of the procedure, the patient became very anxious and the operator stopped rinseback.Patient's vital signs were checked and code met was called.The patient felt fine after a few minutes.The disposable kit is not available for return because it was discarded by the customer.This report is being filed in response to the customer filing a medwatch report ((b)(4)), which was received by terumo bct on 08/15/2014.

Manufacturer Narrative

Investigation: per the customer, the failure of the anticoagulant pump on the cobe spectra machine caused the patient to receive too much anti-coagulant (acda).The biomed troubleshot the issue to a failure of the encoder on the ac pump motor.They replaced the ac and plasma pump motors, the pump driver board, the hall effects switch and the r.A.M batteries.The biomed reportedly ran the unit for one hour with all 4 pumps commanded to 200 rpms with no issues reported.A one year review of the devices service history did not reveal any records related to there ported condition.No additional reports have been received for this device regarding the reported condition.Root cause: failed pump encoder, cause is undetermined.The device failed safe and is now operational.There is no safety risk associated with the reported condition as the machine alarmed as designed.

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.

• Brand Name: COBE SPECTRA BLOOD COLLECTION
• Type of Device: COBE SPECTRA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4077041
• MDR Text Key: 4741049
• Report Number: 1722028-2014-00370
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/15/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 000000000950000000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2014
• Initial Date FDA Received: 09/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/28/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00036 YR
• Patient Weight: 59