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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DATASCOPE FAIRFIELD BO-TOP 47600 LTX W/PEDI HSVR W/ORF32; TUBING, PUMP, CARDIOPULMONARY BYPASS
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DATASCOPE FAIRFIELD BO-TOP 47600 LTX W/PEDI HSVR W/ORF32; TUBING, PUMP, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number 701066549
Device Problems Break (1069); Detachment Of Device Component (1104); Device Damaged Prior to Use (2284); Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2017
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 during circuit set-up and removal of custom tubing pack from sterile tubing pack, clinician noted that the shunt line from the lgb filter had broken off of the filter housing and could not be used.It was found that the shunt line was broken from the housing of the lgb filter when removed from the shipping pack during circuit set-up.There was no patient involvement in this case.
 
Manufacturer Narrative
09/07/2017 (b)(4): product was not sanitized as per investigator request, since it was only primed and was never used on a patient.As per the investigation report, a visual inspection determined that only part of the pack was returned for analysis, however the broken port on the pall lg6 arterial filter was confirmed.As per the investigation report, the most likely cause of the confirmed broken port on the pall lg6 arterial filter was determined to be rough handling.When the rough handling occurred could not be conclusively determined.A lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4); record # (b)(4).09/06/2017 (b)(4): product was not sanitized as per investigator request, since it was only primed and was never used on a patient.Per attached failure evaluation, a visual inspection determined that only part of the pack was returned for analysis,however the broken port on the pall lg6 arterial filter was confirmed.Per attached failure evaluation, the most likely cause of the confirmed broken port on the pall lg6 arterial filter was determined to be rough handling.When the rough handling occurred could not be conclusively determined.A lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.Complaint # (b)(4); record # (b)(4).
 
Event Description
It was reported that during circuit set-up and removal of custom tubing pack from sterile tubing pack, clinician noted that the shunt line from the lgb filter had broken off of the filter housing and could not be used.It was found that the shunt line was broken from the housing of the lgb filter when removed from the shipping pack during circuit set-up.There was no patient involvement in this case.
 
Manufacturer Narrative
Pma/510(k)# changed from : k08059223 to: k080592.Complaint # (b)(4).
 
Event Description
It was reported that during circuit set-up and removal of custom tubing pack from sterile tubing pack, clinician noted that the shunt line from the lgb filter had broken off of the filter housing and could not be used.It was found that the shunt line was broken from the housing of the lgb filter when removed from the shipping pack during circuit set-up.There was no patient involvement in this case.
 
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Brand Name
BO-TOP 47600 LTX W/PEDI HSVR W/ORF32
Type of Device
TUBING, PUMP, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer (Section G)
DATASCOPE FAIRFIELD
15 law drive
fairfield NJ 07004
Manufacturer Contact
dorota wolpiuk
15 law drive
fairfield, NJ 07004
MDR Report Key6756691
MDR Text Key81727444
Report Number2248146-2017-00192
Device Sequence Number1
Product Code DWE
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 company representative,consum
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/29/2018
Device Catalogue Number701066549
Device Lot Number3000026971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/25/2017
Is the Reporter a Health Professional? No
Date Manufacturer Received02/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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