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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD AS LVP 20D DEHP 2SS CV

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CAREFUSION SD AS LVP 20D DEHP 2SS CV Back to Search Results
Model Number GEMINI DISP
Device Problems Break (1069); Corroded (1131); Crack (1135); No Apparent Adverse Event (3189); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2018
Event Type  malfunction  
Manufacturer Narrative
The reported issue that the pump module was placed in a pause state, after the tubing with a 50ml bottle of propofol was installed into the pump, could not be confirmed or duplicated during the investigation. The log analysis found that the received pump module sn (b)(4) was left in an idle state after it had been powered on at 9:21am. The pump module alarmed twice for detection of the safety clamp open around the noon hour. The duration of the safety clamp open alarms was 8 seconds and 7 seconds respectively. The log analysis could not ascertain if the fluid emptied on the floor during the alarms; the user had stated the roller clamp was open and the disposable not connected to the patient when the infusion was setup. The testing and inspection process found no existing malfunctions. No unintended (unregulated) fluid flow was occurring and the pump module infused within specifications. A dhr (device history record) review cannot be completed as the serial number was not obtained upon receipt of the complaint. Additionally, a historical review of complaints in trackwise cannot be conducted. Capa reference: (b)(4).
 
Event Description
The customer reported that the nurse had primed the line with a 50ml bottle of propofol by gravity, inserted the tubing into the pump with the roller clamp open and placed the pump on pause until the start of the procedure. When they were ready to use the pump they noticed the bottle of propofol had emptied onto the floor. The tubing was not connected to the patient.
 
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Brand NameAS LVP 20D DEHP 2SS CV
Manufacturer (Section G)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
caroline joy
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key10807670
MDR Text Key229969542
Report Number2016493-2020-36293
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/15/2020
Device Model NumberGEMINI DISP
Device Catalogue NumberGEMINI DISP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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