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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1 Back to Search Results
Model Number 816570
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/28/2018
Event Type  malfunction  
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, a false "cover door open" message displayed on the screen.There was no patient involvement.
 
Manufacturer Narrative
Per the field service representative (fsr), he replaced the pump.The unit operated to manufacturer's specifications.During laboratory analysis, the product surveillance technician (pst) observed the "cover open" error message due to a defective cover interlock switch.It was observed that there was infinite resistance in open and closed positions, when the closed position should be.01 ohms.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
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Brand Name
ADVANCED PERFUSION SYSTEM 1
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8164749
MDR Text Key131478047
Report Number1828100-2018-00644
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K172220
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number816570
Device Catalogue Number816570
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2019
Was the Report Sent to FDA? No
Date Manufacturer Received01/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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