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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. MEDCOMP CENTRAL VENOUS CATHETER; PERMCATH
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MEDICAL COMPONENTS, INC. MEDCOMP CENTRAL VENOUS CATHETER; PERMCATH Back to Search Results
Model Number UNAVAILABLE
Device Problems Failure To Adhere Or Bond (1031); Connection Problem (2900)
Patient Problems Cardiopulmonary Arrest (1765); Hypovolemia (2243)
Event Date 10/17/2017
Event Type  Death  
Event Description
Approximately 1.5 hours into a scheduled 4 hour hemodialysis treatment, blood was noted on the floor on the right side of the patient's chair.The venous bloodline was detached from the venous lumen of the central venous catheter.The blood pump was stopped and lumen clamped.Patient was unresponsive.Oxygen and aed were applied and cpr initiated.Phone number 911 was called.Normal saline was infused via arterial line.Patient was transported to the hospital via ems, where she later expired.Rn reported that hemaclips were applied to both arterial and venous lines at initiation of treatment.
 
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Brand Name
MEDCOMP CENTRAL VENOUS CATHETER
Type of Device
PERMCATH
Manufacturer (Section D)
MEDICAL COMPONENTS, INC.
harleysville PA 19438
MDR Report Key7003085
MDR Text Key91219205
Report Number7003085
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberUNAVAILABLE
Device Lot NumberUNAVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/26/2017
Distributor Facility Aware Date10/17/2017
Event Location Outpatient Treatment Facility
Date Report to Manufacturer10/26/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age54 YR
Patient Weight111
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