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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYTEM 8000; 8K (PUMP, ROLLER TYPE)
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TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO PERFUSION SYTEM 8000; 8K (PUMP, ROLLER TYPE) Back to Search Results
Model Number 16402
Device Problem Crack (1135)
Patient Problem Not Applicable (3189)
Event Date 05/29/2014
Event Type  malfunction  
Event Description
The field service rep (fsr) reported that during preventative maintenance (pm) of the device, the pump tongue on the roller pump was cracked.Since the event occurred during preventative maintenance, there was no pt involvement.
 
Manufacturer Narrative
Eval is in progress, but not yet concluded.The field service rep (fsr) has ordered a replacement part for the roller pump and will make the required repair at customer site.
 
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Brand Name
TERUMO PERFUSION SYTEM 8000
Type of Device
8K (PUMP, ROLLER TYPE)
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 Key3966093
MDR Text Key4624628
Report Number1828100-2014-00505
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953901
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 05/29/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number16402
Device Catalogue Number16402
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/13/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received05/29/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/01/2001
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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