MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA FX15 OXYGENATOR W/HR AND ART FILTER EAST; BLOOD GAS OXYGENATOR

Model Number 1CX FX15RE40

Device Problems Improper Flow or Infusion (2954); Pumping Problem (3016)

Patient Problem Blood Loss (2597)

Event Date 06/03/2014

Event Type  Injury  

Manufacturer Narrative

Terumo has received the actual device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

The cpb circuit included a fx15 oxygenator and a sarns centrifugal pump head.There were no functional or behavioral issues observed during set-up and priming of the cpb circuit.On the initiation of cpb: blood flow, pump speeds, and oxygenator function were within normal limits and there were no signs of functional issues.The patient was slowly cooled and the aorta was cross clamped ad the 1st dose of cardioplegia was administered.The blood flow was about 5 1/min when the cross-clamp was applied.Over the next 5-10 minutes the blood flow gradually dropped in spite of raising pump speeds.Eventually, only 2.5 1/min of blood flow could be provided at full pump speed (3500 rpm).The circuit line pressure after the oxygenator was 148 mmhg.As the blood flows were dropping gradually the pao2 was also dropping to less than 100 mmhg.The cv surgeon was alerted to the issues and the team elected to change out both the oxygenator and the sarns centrifugal pump.Before the change out was performed, the patient was further cooled to 30 degrees c.When the temperature reached 30 degrees c, the arterial and venous lines were clamped and cpb was halted.The components were removed from the cpb circuit and a like oxygenator and centrifugal pump head were inserted, primed, and debubbled.Cpb was re-initiated and the procedure was completed as scheduled.The time off cpb was 4 minutes and the estimated blood loss was 200 ml.The estimated delay in the procedure was 5 minutes.The patient was weaned from cpb without issue and there was no harm observed in the operating room and in the 1st 12 hours post-op.As the patient was waking up in the icu, the patient was alert and responding to commands, and moving all limbs.About 1:00 am on (b)(6), 2014 the patient began to exhibit stroke-like symptoms and these included left sided weakness and slurred speech.The pump record was reviewed.Between 12:15 -12:45 pm.The blood flow dropped from 5.0 1/min to 2.5 1/min in spite of increasing the pump motor rpm tp 3500 rpm.During this same period, the pao2 dropped from 205 mmhg to 85 mmhg, and the svo2 dropped from 84% to 70% in spite of dropping the temperature to 30 degrees c.There is no indication of a structural issues with the unit and no indication of functional issues with the centrifugal pump head as flow was being produced and no signs/symptoms of decoupling or other functional failures.The pump record did detail that the original fx 15 unit was replaced with a fx 25 sized unit.

• Brand Name: FX15 OXYGENATOR W/HR AND ART FILTER EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho,; fujinomiya, shizuoka, prefecture ; JA
• Manufacturer Contact: eileen dorsey, ra, mgr ; 125 blue ball road; elkton, MD 21921 ; 8002623304
• MDR Report Key: 3931721
• MDR Text Key: 22206647
• Report Number: 9681834-2014-00187
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112229
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 1CX FX15RE40
• Device Lot Number: 130827
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/11/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Manufacturer Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other