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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ERC TUBING CLAMP/ 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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LIVANOVA DEUTSCHLAND S5 ERC TUBING CLAMP/ 620MM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS Back to Search Results
Model Number 60-05-65
Device Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the s5 erc tubing clamp/620mm.The incident occurred in (b)(6).The device was requested back to livanova (b)(4) for further investigation.
 
Event Description
Livanova (b)(4) received a report that a s5 erc tubing clamp was working intermittently.There was no report of patient injury.
 
Manufacturer Narrative
The device was returned to livanova deutschland for further investigation.During the evaluation the reported issue could be confirmed.Fluid ingress inside the device could be determined as root cause of the reported issue.This is a known issue and livanova deutschland has implemented a corrective action to address the reported malfunction.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
 
Event Description
See initial.
 
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Brand Name
S5 ERC TUBING CLAMP/ 620MM
Type of Device
CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
LIVANOVA DEUTSCHLAND
lindberghstr. 25
munich
MDR Report Key8178417
MDR Text Key131342433
Report Number9611109-2018-01419
Device Sequence Number1
Product Code DTQ
Combination Product (y/n)N
PMA/PMN Number
K071318
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number60-05-65
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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