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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP Back to Search Results
Model Number 801041
Device Problems Decreased Pump Speed (1500); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2018
Event Type  malfunction  
Manufacturer Narrative
No consequences or impact to patient. Decreased pump speed, device operates differently than expected. Pump. Evaluation is in progress, but not yet concluded. Per the manufacturer's subsidiary, the pump was set up in the sucker position. It turned in a pulsating manner when in normal start mode.
 
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the pump had an abnormal rotation speed. As a result, an alternate device was employed. The surgical procedure was completed successfully. There was no delay, no blood loss, nor adverse consequences to the patient.
 
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Brand NameLARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
eileen dorsey
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key7330980
MDR Text Key102216191
Report Number1828100-2018-00118
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K022947
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number801041
Device Catalogue Number801041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/14/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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