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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP PERFUSION PACK; CARDIOPULMONARY DEVICE
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DATASCOPE CORP PERFUSION PACK; CARDIOPULMONARY DEVICE Back to Search Results
Model Number BO-TOP 15500
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2011
Event Type  malfunction  
Event Description
Due to material shortage, a metal coil was substituted for a plastic cooling coil in ten packs.The substitution resulted in a tubing segment too short for pump raceway and renders that component in the customer pack unusable.
 
Manufacturer Narrative
It was found by the technician that the reported problem could not be verified as we are unable to mimic the clinical setting.(b)(4).
 
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Brand Name
PERFUSION PACK
Type of Device
CARDIOPULMONARY DEVICE
Manufacturer (Section D)
DATASCOPE CORP
fairfield NJ
Manufacturer Contact
jason de sousa
15 law dr.
fairfield, NJ 07004
9737097256
MDR Report Key4077273
MDR Text Key20972977
Report Number2248146-2014-00396
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/02/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2013
Device Model NumberBO-TOP 15500
Device Catalogue Number701051863
Device Lot Number13023
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2011
Initial Date FDA Received08/22/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2011
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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