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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM-1; APS 1 (ROLLER PUMP)
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM-1; APS 1 (ROLLER PUMP) Back to Search Results
Model Number 801041
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2014
Event Type  malfunction  
Event Description
It was reported that during set-up of the device for a cardiopulmonary bypass procedure, there was a beltslip on the roller pump.The perfusionist (ccp) backed the occlusion and it still has same error.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.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.
 
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Brand Name
TERUMO ADVANCED PERFUSION SYSTEM-1
Type of Device
APS 1 (ROLLER PUMP)
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 Key4366118
MDR Text Key19352719
Report Number1828100-2014-01127
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022947
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 12/10/2014
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 Number801041
Device Catalogue Number801041
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/16/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2014
Initial Date FDA Received12/22/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/01/2004
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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