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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CUSTOM TUBING PACK; CARDIOPULMONARY
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DATASCOPE CORP. CUSTOM TUBING PACK; CARDIOPULMONARY Back to Search Results
Lot Number 17645-04
Device Problem Implant Mobility NOS (Not otherwise specified) (2645)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2015
Event Type  malfunction  
Event Description
Perfusionist was priming a new circuit, when the luer connection on the venous faceplate of the pediatric quadrox broke off and the prime fluid was noted to be leaking.The perfusionist removed this oxygenator and replaced it.The circuit was in the process of priming, so it never impacted a patient.The event occured immediately after removal from packaging.
 
Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4).
 
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Brand Name
CUSTOM TUBING PACK
Type of Device
CARDIOPULMONARY
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR, LLC
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4531670
MDR Text Key16556371
Report Number2248146-2015-00007
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/20/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number17645-04
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/09/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2015
Was Device Evaluated by Manufacturer? No
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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