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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SORIN GROUP USA, INC. CHILDRENS HSP NEW ORLEANS LA 1; CUSTOM PERFUSION PACK
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SORIN GROUP USA, INC. CHILDRENS HSP NEW ORLEANS LA 1; CUSTOM PERFUSION PACK Back to Search Results
Catalog Number 62715903
Device Problem Other (for use when an appropriate device code cannot be identified) (2203)
Patient Problem No Patient involvement (2648)
Event Date 06/10/2014
Event Type  Other  
Event Description
Sorin group received a report that there seemed to be air being pulled in from one of the connectors of the cardioplegia line during priming.There was no patient involvement.
 
Manufacturer Narrative
The involved cardioplegia line was returned to sorin group for evaluation.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
 
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Brand Name
CHILDRENS HSP NEW ORLEANS LA 1
Type of Device
CUSTOM PERFUSION PACK
Manufacturer (Section D)
SORIN GROUP USA, INC.
14401 west 65th way
arvada CO 80004
Manufacturer (Section G)
SORIN GROUP USA, INC.
14401 w 65th way
arvada CO 80004
Manufacturer Contact
cheri voorhes, mgr
14401 west 65th way
arvada, CO 80004
3034676527
MDR Report Key3982843
MDR Text Key4750332
Report Number1718850-2014-00224
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Remedial Action Other
Type of Report Initial
Report Date 06/10/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2015
Device Catalogue Number62715903
Device Lot Number1317000027
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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