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

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.

• 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 Key: 6257533
• MDR Text Key: 64966751
• Report Number: 2050001-2017-00039
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• 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 Number: 980105VSD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2016
• Initial Date FDA Received: 01/17/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention