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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE -SARNS 8000 ROLLER PUMP
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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE -SARNS 8000 ROLLER PUMP Back to Search Results
Model Number 149139
Device Problems Thermal Decomposition of Device (1071); Charred (1086)
Patient Problem No Patient Involvement (2645)
Event Date 11/02/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Per field service representative (fsr), the bent connector pin on the ups cable was straightened and cleaned.The fsr verified the operation of the roller pump.The fsr completed the preventative maintenance and the system operated to manufacturers specifications.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the left hand ups cable connector had a bent/charred pin at male connector to roller pump.There was no patient involvement.
 
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Brand Name
SARNS 8000 UNIVERSAL ROLLER PUMP
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE -SARNS 8000 ROLLER PUMP
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key6128182
MDR Text Key61142900
Report Number1828100-2016-00763
Device Sequence Number1
Product Code DWB
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 Other
Type of Report Initial
Report Date 11/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number149139
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received11/02/2016
Was Device Evaluated by Manufacturer? Yes
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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