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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC ENFLOW WARMER UNIT-D; WARMER, THERMAL, INFUSION FLUID

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CAREFUSION, INC ENFLOW WARMER UNIT-D; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Catalog Number 980105VSD
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/20/2016
Event Type  Injury  
Manufacturer Narrative
Initial esubmission: customer stated device is available for evaluation.To date carefusion/bd is waiting for the device to be returned for further evaluation.If any additional information becomes available a supplemental submission will be filed.(b)(4).
 
Event Description
We have had a case of the enflow warmer producing false arrhythmias on the ekg in the or.There was a case where the fluid warmers contributed to the appearance of false arrhythmias on our philips monitors.There was no patient harm, but i believe that iv lidocaine was given for this case.The patient was intubated under general anesthesia.
 
Manufacturer Narrative
Follow up submission: investigation results the reported enflow warmer serial number (b)(4) was returned to vyaire medical and re-tested to our standard quality control test procedures.The unit passed operational testing.The returned unit was also re-tested for patient leakage safety testing, radiated emissions testing, and conducted emissions testing in accordance with (b)(4).(b)(4) is a series of technical standards governing the safety and effectiveness of medical electrical equipment.The investigation concluded the enflow warmer was within the product¿s and (b)(4) specifications.Through further evaluation a potential conducted noise signature in samples with the latest design was identified which is well below the (b)(4) requirements however, this interference may occur under very unique circumstances with more highly sensitive ecg instruments in the field.Vyaire medical has performed a deep dive investigation to identify possible mitigation to further reduce the conducted noise signature with highly sensitive ecg instruments and is working on future product improvements based on these results.
 
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Brand Name
ENFLOW WARMER UNIT-D
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
CAREFUSION, INC
22745 savi ranch parkway
yorba linda CA 92887
Manufacturer (Section G)
HEALTHCARE TECHNOLOGY INTL LTD
yin yang industrial estate, zh
dongguan 53262 0
CH   532620
Manufacturer Contact
jill rittorno
22745 savi ranch parkway
yorba linda, CA 92887
MDR Report Key6257533
MDR Text Key64966751
Report Number2050001-2017-00039
Device Sequence Number1
Product Code LGZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130867
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number980105VSD
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/30/2016
Initial Date FDA Received01/17/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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