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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT, INC. COBE/SPECTRA; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
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TERUMO BCT, INC. COBE/SPECTRA; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC Back to Search Results
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem Overdose (1988)
Event Date 05/09/2014
Event Type  malfunction  
Event Description
Doing a plasma exchange with a cobe spectra.The machine malfunctioned and gave the patient a bolus of acda.It was a failure of the acda pump that caused the patient to receive too much acda.Manufacturer response for dialysis, (brand not provided) (per site reporter).
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after completing the interrogation on the system, below are our findings: the failure of the encoder in the anticoagulant (ac) pump motor causing the motor to go into run away mode giving a f20 error code was the only reason for the failure.As precautions the ac, plasma pump motors, pump driver board, hall effects switch, r.A.M batteries were replaced and full pm was performed to insure proper performance.Unit ran for one hour with all four motors at 200rpms no errors occurred.
 
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Brand Name
COBE/SPECTRA
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
Manufacturer (Section D)
TERUMO BCT, INC.
10811 west collins ave.
lakewood CO 80215
MDR Report Key3959521
MDR Text Key4562442
Report Number3959521
Device Sequence Number1
Product Code GKT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/02/2014
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 Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/02/2014
Event Location Hospital
Date Report to Manufacturer07/28/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/02/2014
Patient Sequence Number1
Treatment
DIALYSIS
Patient Age36 YR
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