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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
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYSTEM 8000; 8K Back to Search Results
Model Number 95274
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/25/2014
Event Type  malfunction  
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, he discovered the level sensor located on the perfusion system was not working.There was no patient involvement.
 
Manufacturer Narrative
Evaluation is in progress, but not yet concluded.Per the fsr, the polyurethane membrane has been damaged and the cord has been pinched.The fsr removed the level sensor and ordered another one and had it shipped to the hospital.Preventive/corrective maintenance was completed successfully.The unit operated to manufacturer specifications and was returned to clinical use.
 
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Brand Name
TERUMO PERFUSION SYSTEM 8000
Type of Device
8K
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 Key4355827
MDR Text Key5222933
Report Number1828100-2014-01088
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K915183
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number95274
Device Catalogue Number195274
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received11/25/2014
Was Device Evaluated by Manufacturer? No
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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