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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV BLOWER MISTER WITH IV SETS; LAVAGE, JET
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MAQUET CV BLOWER MISTER WITH IV SETS; LAVAGE, JET Back to Search Results
Catalog Number C-CB-1000
Device Problems Obstruction of Flow (2423); No Flow (2991)
Patient Problem No Patient Involvement (2645)
Event Date 10/15/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using blower mister with iv sets.When hospital plugged in to be used, they noticed the co2 would not flow and discovered it was occluded.A replacement device was used to complete the procedure.No patient involvement.
 
Manufacturer Narrative
Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).The device was returned to the factory for evaluation.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.The device was received in pieces.The handle was observed to be taken apart with the tubing removed.The blower mister end was observed to be intact.There were no visual defects observed on the blower mister tubing.Based on the return condition of the device, we are unable to confirm the reported failure "no flow" due to the fact that the device was returned in pieces.Because this is a oem component, the c of c was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.
 
Event Description
The hospital reported that during a coronary artery bypass procedure using blower mister with iv sets.When hospital plugged in to be used, they noticed the co2 would not flow and discovered it was occluded.A replacement device was used to complete the procedure.No patient involvement.
 
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Brand Name
BLOWER MISTER WITH IV SETS
Type of Device
LAVAGE, JET
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key8044576
MDR Text Key126656031
Report Number2242352-2018-01104
Device Sequence Number0
Product Code FQH
PMA/PMN Number
K983135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/02/2018
Device Catalogue NumberC-CB-1000
Device Lot Number96255607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/22/2018
Date Manufacturer Received12/18/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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