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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
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EDWARDS LIFESCIENCES DR PRESSURE MONITORING SET; VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM Back to Search Results
Model Number PXVJ050M
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.
 
Event Description
As reported, when priming before use with patient of this disposable pressure transducer with vamp junior, the tubing broke off from the vamp, leading to leakage.There was no allegation of patient injury.Patient demographics unable to be obtained.The product was available for evaluation.
 
Manufacturer Narrative
The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.
 
Event Description
As reported, when priming before use with patient of this disposable pressure transducer with vamp junior, the tubing broke off from the vamp, leading to leakage.There was no allegation of patient injury.Patient demographics unable to be obtained.The product was available for evaluation.
 
Manufacturer Narrative
One pressure monitoring set with vamp jr was received by our product evaluation laboratory for a full examination.The report of tubing issue was confirmed.However, instead of being separated, the pressure tubing was found completely broken from the distal bond joint with vamp jr.Reservoir.Cross surfaces of broken tubing appeared rough and uneven.No other visible damage was observed from returned kit.Tubing breakage is a unique issue that has been investigated and the root cause is a combination of excess solvent and stress on a portion of the tubing in the package.If tubing breakage occurs during use, it would most likely be identified by a small amount of fluid or blood loss.With this device there was no blood loss.The system can be exchanged with a minimal delay in treatment or monitoring.As such, this event is no longer considered reportable and a corrected supplemental report is being submitted.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
 
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Brand Name
PRESSURE MONITORING SET
Type of Device
VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION SYSTEM
Manufacturer (Section D)
EDWARDS LIFESCIENCES DR
parque industrial de itabo
carr. sanchez km 18.5
haina , san cristobal
Manufacturer Contact
samantha eveleigh
1 edwards way
irvine, CA 92614
9492503939
MDR Report Key12967450
MDR Text Key285187951
Report Number2015691-2021-06737
Device Sequence Number1
Product Code DXO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173586
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/27/2022
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 Model NumberPXVJ050M
Device Lot Number63491127
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2021
Initial Date FDA Received12/09/2021
Supplement Dates Manufacturer Received01/05/2022
Supplement Dates FDA Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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