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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP

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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1 PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP Back to Search Results
Model Number 801041
Device Problem Image Display Error/Artifact (1304)
Patient Problem No Patient Involvement (2645)
Event Date 10/17/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The reported complaint was confirmed. During laboratory analysis, the product surveillance technician (pst) observed the display to have distorted graphics. Pst replaced customer graphics driver board with lab use only graphics driver board, which restored functionality of display. It was determined customer graphics driver board was defective. If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
 
Manufacturer Narrative
(b)(4). This unit is a test unit and not used clinically. The fsr installed a new display assembly. The unit operated to the manufacturer's specifications. The suspect part was returned to the manufacturer for further evaluation.
 
Event Description
The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the pump display would continually flash lines with no legible text. There was no patient involvement.
 
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Brand NameLARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1
Type of DevicePUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ 6 INCH ROLLER PUMP
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
Manufacturer Contact
katie hoyt
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key7010980
MDR Text Key247789685
Report Number1828100-2017-00511
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163531
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/08/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number801041
Device Catalogue Number801041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/27/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2002
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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