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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 UNIVERSAL ROLLER
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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION SARNS 8000 UNIVERSAL ROLLER PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE ¿ SARNS 8000 UNIVERSAL ROLLER Back to Search Results
Model Number 16402
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2018
Event Type  malfunction  
Manufacturer Narrative
The reported issue was discovered during student setup training.As per the field service representative (fsr), the occlusion knob was very hard to turn, which had probably led to the broken tongue thus knob was cleaned and lubricated.He replaced the tongue.The suspect device will be returned to the manufacturer for further evaluation.
 
Event Description
It was reported that during the use of the device for a non-clinical activity, the molded tongue of the pump was broken.There was no patient involvement.
 
Manufacturer Narrative
The reported complaint was confirmed.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 UNIVERSAL ROLLER
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
6200 jackson road
ann arbor MI 48103
MDR Report Key7965895
MDR Text Key123825855
Report Number1828100-2018-00551
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,health
Type of Report Initial,Followup
Report Date 11/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number16402
Device Catalogue Number16402
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Was the Report Sent to FDA? No
Date Manufacturer Received11/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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