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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 21730224
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Via spontaneous call, patient's wife reported faulty cassettes. She stated that when they push the syringe containing drug/ diluent into the cassette (lot 21730224), the medication leaks from the connector and within the cassette. She said that it looks like the cassette pops from the inside. She can see solution outside of the cassette's inner bag. She said this is the 5th time this has happened since switching from (b)(6). Pt currently has 2 mixes already made and they are going to try to make one more mix as backup mix, but they are concerned because they are having to waste drug due to these faulty cassettes. Asked patient's wife if they had extra cassettes that are of a different lot number. She stated they are all the same lot - 21730224. Advised her that we will ship 30 cassette medi reservoirs of a different lot and see if that fixes this issue. No other information or dates known. Did the pt have a backup device they were able to switch to? yes; if yes, was the pt able to successfully continue their infusion? yes, is the infusion life-sustaining? yes, what is the outcome of the event? resolved. Did the reported product fault occur while in use with a pt? yes; did the product issue cause or contribute to pt or clinical injury? no; is the actual device is available to be returned for investigation? yes. Did we replace device? yes. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCASSETTE MEDI RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12624128
MDR Text Key276644169
Report NumberMW5104548
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 04/30/2021
5 Devices were Involved in the Event: 1   2   3   4   5  
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number21730224
Was Device Available for Evaluation? No Answer Provided
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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