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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSIO SYSTEM 1; APS 1 (ROLLER PUMP)
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSIO SYSTEM 1; APS 1 (ROLLER PUMP) Back to Search Results
Model Number 801040
Device Problems Device Operates Differently Than Expected (2913); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 10/10/2014
Event Type  malfunction  
Event Description
After use of the device for a cardiopulmonary bypass procedure, the user reported the roller pump was not working, but power was supplied.The unit was not operating until an abnormal noise was heard, then the roller pump operated normal.There were no reported adverse consequences to the patient.
 
Manufacturer Narrative
The subsidiary's manufacturing engineering ctr (mec) could not duplicate the reported issue.
 
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Brand Name
TERUMO ADVANCED PERFUSIO 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 Key4340546
MDR Text Key19314935
Report Number1828100-2014-01043
Device Sequence Number1
Product Code DTQ
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 Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number801040
Device Catalogue Number801040
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/01/2005
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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