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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NEEDLE FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION NEEDLE FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2000E
Device Problem Restricted Flow rate (1248)
Patient Problem Death (1802)
Event Date 07/16/2018
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: d-60hl rapid infuser tubing, continu-flow solution set, 10 drops/ml product number: 2c8541, therapy date: (b)(6) 2018. No product will be returned per customer. The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that the patient needed the use of pressure bags and a level 1 rapid infuser for multiple infusions and transfusions through multiple central lines. The users noticed impeded flow during the infusions. The rapid infuser and the tubing that appeared to be malfunctioning were replaced and the customer ensured that each iv port was flowing adequately, however the decreased flow rate continued. After placement of another large bore central line, the flow issue persisted. The physician felt that the needle free valve did not tolerate the high pressure required and may not have been compatible with the infuser tubing. A non-bd needlefree valve was used instead with no issues. The patient was further resuscitated, was later placed on comfort care, and passed away. An autopsy was declined by the patient's family and attending physicians. The customer does not believe the product issue caused the patient's death.
 
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Brand NameNEEDLE FREE VALVE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7769138
MDR Text Key116631311
Report Number9616066-2018-01256
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2000E
Device Catalogue Number2000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/09/2018 Patient Sequence Number: 1
Treatment
(2) LEVEL 1 RAPID INFUSER, THERAPY DATE: (B)(6) 2018
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