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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD INC CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 3630804
Device Problems Restricted Flow rate (1248); Material Twisted/Bent (2981)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
Event Description
Patient reports that cassettes lot# 3630804 are poorly manufactured. She states that the neck on the bladder gets pinched off when administering medication through her pump which result in her feeling very ill because she is not getting medication at the correct rate-she states that the bladder on the cassettes are ¿bent¿ on all sides and when you put liquid in them, they form an ¿s¿ shape which affects the flow of liquid through the pump. She tried 4 different cassettes yesterday and as of¿¿ they were faulty. Patient is keeping the malfunctioning cassettes for return to the mfr. No further information available. Reported to (b)(6) by: patient/caregiver. Strength: 12x 100ml. Dose or amount: veletri 37. 417 ng/kg/min, frequency: continuous, route: intravenously. Dates of use: from (b)(6) 2017 to ongoing. Diagnosis or reason for use: primary pulmonary hypertension.
 
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Brand NameCASSETTE MEDI RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD INC
MDR Report Key8141980
MDR Text Key129884199
Report NumberMW5081918
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/21/2018
4 Devices were Involved in the Event: 1   2   3   4  
0 Patients were Involved in the Event:
Date FDA Received12/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3630804
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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