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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K (PUMP, ROLLER TYPE)
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K (PUMP, ROLLER TYPE) Back to Search Results
Model Number 16402
Device Problems Sticking (1597); Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/17/2014
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the roller pump was sticking and the perfusionist (ccp) was not able to occlude.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.
 
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Brand Name
TERUMO PERFUSION SYSTEM 8000
Type of Device
8K (PUMP, ROLLER TYPE)
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson rd.
ann arbor, MI 48103
7346634145
MDR Report Key4219236
MDR Text Key4975550
Report Number1828100-2014-00662
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16402
Device Catalogue Number16402
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/17/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2005
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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