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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOPLEGIA PACK 4:1; CARDIOPULMONARY DEVICE

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DATASCOPE CORP. CARDIOPLEGIA PACK 4:1; CARDIOPULMONARY DEVICE Back to Search Results
Model Number BEQ-T 4961
Device Problem Temperature Problem (3022)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2014
Event Type  malfunction  
Event Description
Chief of perfusion at the facility reported that the plegiox in his custom plegia set is not cooling below 10c, so he cut out the plegiox and replaced it.It was noticed that the temperature port was not all the way down into the luer port so it was not coming into complete contact with the blood.No pt injury or death was reported in this case.
 
Manufacturer Narrative
The component was not returned for eval.If the product becomes available, an eval will be performed and a follow-up report submitted.Maquet has submitted an 806 notification for this component under #8010762-1/31/2014-001c.A "z" number had not yet been assigned.
 
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Brand Name
CARDIOPLEGIA PACK 4:1
Type of Device
CARDIOPULMONARY DEVICE
Manufacturer (Section D)
DATASCOPE CORP.
fairfield NJ
Manufacturer Contact
jason sousa
15 law dr.
fairfield, NJ 07004
9737097256
MDR Report Key3787366
MDR Text Key19584594
Report Number2248146-2014-00006
Device Sequence Number1
Product Code DWF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date 01/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberBEQ-T 4961
Device Catalogue Number701066914
Device Lot NumberASKU
Other Device ID Number70092153
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/16/2014
Initial Date FDA Received02/10/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age83 YR
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