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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM

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TERUMO CARDIOVASCULAR SYSTEMS CORP. SARNS CENTRIFUGAL SYSTEM CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM Back to Search Results
Model Number 6382
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation is in progress, but not yet concluded. Per the field service representative (fsr): the customer reported he found the flow sensor that someone else had set aside. He did not have any date of occurrence, just that it had been removed from service and placed aside. Later, the ccp contacted me stating that the sensor reportedly would not stay closed after it was placed on the tubing. There was no patient involvement. The fsr tested the flow sensor but could not duplicate the reported issue. The fsr removed the suspect flow sensor from service. The customer have a spare flow sensor that is in use until a replacement sensor is ordered and delivered to them. The unit operated to manufacturer specifications and was returned to clinical use. The suspect part was 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 flow sensor would not stay closed after it was placed on the tubing. There was no patient involvement.
 
Manufacturer Narrative
(b)(4). The reported issue was confirmed. During the laboratory evaluation, the flow sensor would not stay closed after it was placed on tubing. The flow sensor was able to measure flow. The product surveillance technician (pst) connected the flow sensor to a centrifugal control module and it read flow when attached to a water loop. The issue was isolated to wear found on the cover latch, causing the latch to not stay closed. 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 NameSARNS CENTRIFUGAL SYSTEM
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS - SARNS CENTRIFUGAL SYSTEM
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORP.
6200 jackson road
ann arbot MI 48103
Manufacturer Contact
jan winder
6200 jackson road
ann arbor, MI 48103
7346634145
MDR Report Key5508088
MDR Text Key40791732
Report Number1828100-2016-00192
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K950739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/17/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number6382
Device Catalogue Number6382
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/03/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/1999
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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