MAUDE Adverse Event Report: CAREFUSION ENFLOW CONTROLLER UNIT; CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC

Model Number 980121EU

Device Problems Device Alarm System (1012); Insufficient Heating (1287); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2014

Event Type  Injury  

Event Description

Original complaint description: at the end of the case ¿ the charge tech who was in the case for the duration went to disconnect the enflow cartridge which had been under the drapes throughout the case ¿ and noticed that the cartridge and warmer were cold.  he said that throughout the case, the display on the control unit was 40 degrees and did not alarm.  they had noticed that the patient was slightly cold but because the temp on the control unit said 40 degrees did not think that it was due to the fluid.  the cartridge was thrown away at the end of the case.  the biomeds checked the unit with the encheck and it has passed the test.  the customer have concluded that there must have been something wrong with the cartridge itself.  the ct said that the cartridge was in properly and the doors on the warmer were shut.No patient impact.Updated information indicates that the complaint should now be against the warmer (lot 90814703) instead of the cartridge.This complaint is a split ticket from the original complaint and was opened against the controller for not displaying an alarm when the warmer was not heating.Note: the aware date of (b)(6) 2015 is the date that the additional issue (no alarm generated) was identified.

Manufacturer Narrative

(b)(4).There was no return sample to investigate to determine the root cause and the lot number is unknown.The customer indicated that they returned the device to use at their facility and it has since returned normal function.A complaint search was performed.Elevated complaint activity related to the customer's observation was not identified.The reported issue will continue to be trended and monitored.

Manufacturer Narrative

This supplemental is being filed due to a retrospective review of mdr submissions.Corrections and additional information has been completed.(b)(4).

• Brand Name: ENFLOW CONTROLLER UNIT
• Type of Device: CONTROLLER, INFUSION, INTRAVASCULAR, ELECTRONIC
• Manufacturer (Section D): CAREFUSION; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTL LTD; yin yang industrial estate, zh; dongguan, guangdong 53262 0; CH 532620
• Manufacturer Contact: jill rittorno ; 75 north fairway drive; vernon hills, IL 60061 ; 8473628056
• MDR Report Key: 4572864
• MDR Text Key: 17690897
• Report Number: 2242551-2015-00020
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Distributor,consumer,distribu
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: 980121EU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention