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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD CUSTOM ECC TUBE PACK BEQ-TOP 50903; TUBING, PUMP, CARDIOPULMONARY BYPASS
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DATASCOPE FAIRFIELD CUSTOM ECC TUBE PACK BEQ-TOP 50903; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 709000078
Device Problems Break (1069); Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 12/15/2018
Event Type  malfunction  
Manufacturer Narrative
The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
 
Event Description
It was reported that upon opening of the custom ecc tube pack beq-top 50903 it was noted the quadroxid luer-lock access port with pigtail on arterial side of oxygenator was broken off.This was noted when the device was being pre-connected and set-up.There was no patient involvement and therefore no reported injury.
 
Event Description
It was reported that upon opening of the custom ecc tube pack beq-top 50903 it was noted the quadroxid luer-lock access port with pigtail on arterial side of oxygenator was broken off.This was noted when the device was being pre-connected and set-up.There was no patient involvement and therefore no reported injury.
 
Manufacturer Narrative
The oxygenator was returned for review for the broken port on the quadrox-i adult without filter (part #701053325; batch #70124039).The associated tray and packaging was not returned and could not be reviewed for damage.The reported complaint was confirmed.Based on the investigation the most likely root cause of the broken oxygenator port can be attributed to rough handling during use by the customer.A lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Complaint # (b)(4), record # (b)(4).
 
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Brand Name
CUSTOM ECC TUBE PACK BEQ-TOP 50903
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
MDR Report Key8213995
MDR Text Key132074314
Report Number2248146-2019-00009
Device Sequence Number1
Product Code DWE
Combination Product (y/n)N
PMA/PMN Number
K08059223
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Catalogue Number709000078
Device Lot Number3000075337
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Date Manufacturer Received01/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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