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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; CENTRAL VENOUS CATHETER
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; CENTRAL VENOUS CATHETER Back to Search Results
Device Problems Loose or Intermittent Connection (1371); Premature Separation (4045)
Patient Problems Dyspnea (1816); Dyspnea (1816); Nausea (1970); Nausea (1970); Hypovolemia (2243); Blood Loss (2597)
Event Date 09/24/2018
Event Type  Injury  
Event Description
Approx 3.75 hours into a scheduled 4 hour hemodialysis treatment, pt complained of shortness of breath and nausea.Bloodlines had been reversed earlier in the treatment.Staff member noted that the venous bloodline was loose from the cvc arterial limb with the hemaclip intact.Ebl 400-500ml.Pt was alert and oriented x 3, but complained of shortness of breath with shallow and labored breathing noted.Pt was placed on o2 cylinder 10 ml non-rebreather mask and placed on her left side in trendelenburg.Bloodlines were clamped and the treatment was discontinued.Ems was notified and arrived in approx ten mins.Vital signs upon discharge from facility: b/p: 112/55; pulse: 68; respirations: 16; temp: 97.5.Pt was transported to the hospital and admitted.
 
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Brand Name
UNK
Type of Device
CENTRAL VENOUS CATHETER
MDR Report Key7995189
MDR Text Key241262814
Report Number7995189
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 10/08/2018
2 Devices were Involved in the Event: 1   2  
2 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/09/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number0
Patient Outcome(s) Hospitalization;
Patient Age64 YR
Patient Weight53
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