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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000 Back to Search Results
Model Number 16402
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
The fsr replaced the broken occluder tongue.The unit operated to the manufacturer's 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 occlusion tongue was broken.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the molded pump tongue to be broken into three pieces.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
SARNS 8000 UNIVERSAL ROLLER PUMP
Type of Device
PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE - SARNS 8000
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key8894254
MDR Text Key154319441
Report Number1828100-2019-00435
Device Sequence Number1
Product Code DWB
Combination Product (y/n)N
PMA/PMN Number
K953901
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2019
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? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Was the Report Sent to FDA? No
Date Manufacturer Received10/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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