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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 Connection Problem (2900); Mechanics Altered (2984)
Patient Problem No Information (3190)
Event Date 10/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.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, while hooking up the blower mister to a co2 tank there was no connector on the braided line and the line was shorter than usual and the disk filter was just shoved inside the tubing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
(b)(4).The device was returned to the factory for evaluation.Signs of clinical use and no evidence of blood were observed.A visual inspection was conducted.The blue connector was intact and showed no signs of defects.Only one part of the blow mister was returned.The braided (0.64 cm) was intact and no visual defects were observed.No iv tubing was returned.Based on the condition of the returned device, the reported complaint "missing component" was not confirmed.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, while hooking up the blower mister to a co2 tank there was no connector on the braided line and the line was shorter than usual and the disk filter was just shoved inside the tubing.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
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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
Manufacturer (Section G)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
Manufacturer Contact
45 barbour pond drive
wayne, NJ 07470
MDR Report Key6089388
MDR Text Key59968433
Report Number2242352-2016-01113
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K030512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/13/2016
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 Date03/31/2018
Device Catalogue NumberC-CB-1000
Device Lot Number96255553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/01/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/13/2016
Initial Date FDA Received11/09/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2016
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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