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Catalog Number ZZ*FX15RE30
Device Problem Infusion or Flow Problem (2964)
Patient Problems Congestive Heart Failure (1783); Pulmonary Edema (2020)
Event Date 07/20/2017
Event Type  Injury  
Manufacturer Narrative
This report is being submitted as follow up number 1 to provide additional information obtained. Further investigation of this complaint determined the product code and lot number initially identified and resulted in mdr 9681834-2017-00177 being submitted, was incorrect. During re-investigation the correct product code and lot number has been identified and determined the reporting obligation is not of terumo ashitaka site. This is the follow-up report to replace the previous incorrect information.
Manufacturer Narrative
Udi number for this product code is not required. The actual device, due to the patient having hepatitis c, was not returned to the manufacturing facility for evaluation. The investigation results were limited to the information provided by the user facility and a retention sample from the involved product/lot number combination. Visual inspection of the retention sample found no anomalies. The retention sample was tested for its gas transfer performance in accordance to the factory's shipping inspection protocol. Bovine blood arranged (hb12. 0 g/dl, temp. 37°c, ph: 7. 4, svo2:65% and pvco2:45 mmhg) was circulated in the oxygenator module under the following conditions: @ v/q
1, fio2
100% and the flaw rate of 5 l/min. And 3 l/min. The result obtained from the test is as follows. O2 transfer: @5 l/min.
341 ml/min. @3 l/min.
224 ml/min. Co2 removal: @5 l/min.
264 ml/min. @3 l/min.
174 ml/min. No anomalies were revealed in the gas transfer performance of the retention sample, with the obtained values meeting the factory specifications. A review of the device history record and the function test/inspection record of the involved product code/lot number combination was conducted with no relevant findings. A search of the complaint file found no other complaints of this nature with the product code/lot number combination. There is no evidence this event was related to a device defect of malfunction. The investigation results verified the retention sample was the normal product. While the exact cause of the reported event cannot be definitively determined based on the available information, the following factors can be inferred. The circulation flow rate was not sufficient for the patient's body surface area. This led svo2 to decrease, resulting in a decrease in pao2. Due to inadequate v/q ratio, o2 supply came to insufficient for the patient's o2 consumption. This led svo2 to decrease, resulting in a decrease in pao2. Due to a low fio2, o2 supply came to insufficient for the patient's o2 consumption. This led svo2 to decrease, resulting in a decrease in pao2. Due to the wet lung phenomenon, water drops accumulated inside the fiber, resulting in the degradation of the gas transfer performance. Blood clots formed in the oxygenator module prevented the gas from having contact with blood, resulting in the degradation of the gas transfer performance. The patient's metabolism was activated by warming and the patient's o2 consumption volume exceeded o2 supply volume. (b)(4). All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event Description
The user facility reported gas exchange failure in the capiox device during a procedure. Follow up communication with the user facility confirmed the following information: during cardiopulmonary bypass it was reported the oxygenator had a gas exchange failure and was unable to oxygenate the patient; the first pump run was long but uneventful, the patient came off bypass without any difficulties; no blood products were needed and there were no issues with management of the patient during cpb and post-cpb in the (operating room) o. R. ; the procedure consisted of an avr, mvr, and tv ring; pump run was 151 minutes and cross-clamp was 95 minutes; the patient's bsa was 2. 47 meters squared; it was reported there were no unusual coagulopathy post-cpb; the customer removed a few liters of fluid via hemoconcentration during cpb; the customer indicate this was a very sick patient right from the start; during the initial cpb run, it was noticed when the blood was sitting idle in the chamber of the cardioplegia device there was a whitish milky layer on the top layer of the blood (when blood settles out you usually see plasma on top); the customer had problems oxygenating the patient in the icu, nitric oxide therapy was tried, it did not help; the patient had been stable from a cardiac perspective then went into full blown congestive heart failure and pulmonary edema in the icu post-op, the patient could not be ventilated; the patient was taken back to the (operating room) o. R. ; the customer called duke university to come put the patient on ecmo and transfer the patient to duke; when they got the patient to the (operating room) o. R. Fluid was pouring out of the endotracheal tube, it was estimated they sucked out about two liters of fluid out of the patient's lungs (the customer described it as the patient was drowning); the customer put the patient back on cpb while waiting for the duke team to arrive to put the patient on ecmo; the patient was placed on cpb with an fx25rec, patient oxygenation improved, lactate levels were higher than measurable; both the cdi 500 and gem premier 3500 devices were used for blood gas monitoring; there was no high pressure excursion, the roller pump was used for their arterial pump. ; the po2 values steadily decreased and the pco2 values increased over time from 2200 to 0140; at 0140 the po2 and pco2 were in the 50s so they partially filled up the heart and had anesthesia start ventilating to help oxygenate the patient; the po2 increased to 73 at 0155; once the patient was placed on the ecmo circuit, gas exchange significantly improved with the po2 in the 400s and pco2 in the mid-30s. ; it was reported, after seeing the settling out of the blood in the cardioplegia circuit during the first pump run, the customer was thinking there was some protein/platelet activation occurring which was clogging the fibers in the oxygenator resulting in the decline in gas exchange performance; when the patient was transferred from cpb to ecmo, the perfusionist drained the cpb circuit and indicated the fiber bundle was clean (no fibrin or clot on the fibers) when the blood was sucked over to cell saver; the customer indicated the act values were >1000 most of the time; the last act before the patient was transported was 635 when on ecmo; and the pump was not changed out and the procedure was not completed successfully.
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Manufacturer (Section D)
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
terry callahan
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
MDR Report Key6799851
MDR Text Key246484354
Report Number9681834-2017-00177
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberZZ*FX15RE30
Device Lot Number170516
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/16/2017
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: 08/17/2017 Patient Sequence Number: 1