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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 Problem Obstruction of Flow (2423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/29/2018
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 an endoscopic vein harvesting procedure using blower mister with iv sets.They stated saline would not flow through device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Event Description
The hospital reported that during an endoscopic vein harvesting procedure using blower mister with iv sets.They stated saline would not flow through device.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
 
Manufacturer Narrative
Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).The certificate of conformance was reviewed.The vendors conform that the device lot conforms to all applicable product specifications.There were no non-conformities observed.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.No visual defects were observed.A mechanical evaluation was conducted.Following the instructions in ifu.The braided (0.64cm) tube was connected to the regulated source of c02 set with not more than 50 psi.The flow control for the saline was adjusted between 5 l/min (0.08 l/s).Care was taken that it doesn't exceed 8 l/min.The pinch clamp on iv tubing was closed and the iv spike was connected to a new bag of sterile saline with pressure cuff around it.After opening the pinch clamp, the sterile saline flowed through the tube.It was observed that there was no co2 flow through the atraumatic tip of the blower mister.The flow volume controller on the hand piece was manipulated forward and backward but it was observed that there was still no flow of co2.No audible sound of the c02 gas was heard at the atraumatic tip.Further inspection was conducted.The hand piece was opened.To determine patency of the tubes, a blue dyed saline fluid was injected into the saline port.There were no blockages and the fluid flowed through all the way to the tip and out it dripped.The same test was conducted on the co2 tube.The fluid did not flow through the tube and resistance was felt when the fluid was pushed into the co2 tube.The resistance indicated blockage in the co2 tube.On microscopic inspection, it was observed that there was obstruction caused by the uv glue at the connection site of the co2 gas tube and the coupler.There were signs of glue migration, resulting in the obstruction and blockage of the co2 air flow track.Based on the returned condition of the device and the investigation results, the reported failure "no flow" was confirmed.The certificate of conformance was reviewed.The vendors conform that the device lot conforms to all applicable product specifications.Field action plan was implemented and shipping hold has been implemented for affected lot numbers.Specific actions for the reported confirmed failure mode are being maintained and documented under maquet's health hazard evaluation (hhe) system.
 
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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 Key8179326
MDR Text Key131141469
Report Number2242352-2018-01314
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
PMA/PMN Number
K983135
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup
Report Date 12/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue NumberC-CB-1000
Device Lot Number96255609
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Date Manufacturer Received01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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