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Catalog Number CX-XRX25201
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  Injury  
Manufacturer Narrative
Weight - (b)(6). Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. 510k - k130520. The patient's height: 181cm and bsa: 2. 06m2. The actual sample was received for evaluation. Visual inspection revealed that the actual sample did not have any obvious anomalies, such as a break that could lead to poor gas transfer performance, in the appearance. The actual sample, after rinsed and dried, was tested for its o2 transfer and co2 removal performance in accordance with the factory's shipping inspection protocol. Blood conditions: bovine blood arranged to hb:12. 0g/dl, temp. :37°c; circulation conditions: flow rate: 6l/min. And 4l/min. , v/q: 1, fio2:100%; result: o2 transfer: @6l/min. : 397ml/min. @4l/min. : 286ml/min; co2 removal: @6l/min. : 328ml/min. @4l/min. : 236ml/min. No anomalies were revealed in the gas transfer performance of the actual sample, with the obtained values meeting the factory specifications. Reproductive testing was performed with the actual sample simulating the situation where pao2 decreased at 8:38 and pao2 increased at 8:45. At 8:38 when pao2 decreased. Bovine blood arranged to the same blood condition as those of the blood gas data read at 8:38, was circulated in the rinsed actual sample under the below circulation condition. Blood flow rate: 4. 48l/min, gas flow rate: 3. 56l/min, hb: 12. 3g/dl, and fio2: 76. 3%. When svo2 was 58%, pao2 was 102mmhg, which was close to 105. 3mmhg read at 8:38. When fio2 was 100%, pao2 was found to be 279mmhg. Circulation condition at 8:36: blood flow rate: 4. 68l/min, gas flow rate: 3. 56l/min, hb: 12. 3g/dl, fio2:76. 3%, blood temp. : 36. 6°c. At 8:45 when pao2 increased. Bovine blood arranged to the same blood condition as those of the blood gas data read at 8:45, was circulated in the rinsed actual sample under the below circulation condition. Blood flow rate: 4. 69l/min, gas flow rate: 3. 36l/min, hb: 11. 7g/dl, and fio2: 89. 8%. When svo2 was 58%, pao2 was 220mmhg, which was close to 223. 63mmhg read at 8:45. Circulation condition at 8:45: blood flow rate: 4. 69l/min, gas flow rate: 3. 36l/min, hb: 11. 7g/dl, fio2:89. 8%, blood temp. : 36. 6°c. A review of the device history record and product release decision control sheet of the product code/lot# combination was conducted with no findings. Review of the pump record involved in this complaint obtained revealed that the pump was on at 03:18 with flow rate of 3. 00l/min, gas flow rate of 1. 94l/min, and fio2 of 58. 4%. At 4:21, circulation was partially stopped. At 6:27, full flow was started. From 8:10 (in five hours after pump on) to 8:38, pao2 decreased from 218mmhg to 105mmhg and fio2 was changed from 76% to 90%. Afterward, pao2 increased up to 223. 6mmhg. At 3:49, cooling started. At 3:52, arterial temperature was found to have decreased to 19. 3°c. From 3:52, arterial temperature was increased gradually up to 36. 0 °c around 7:00. Pao2 stared to decrease at 7:19. At 11:01, the oxygenator was exchanged. At 11:06, blood flow rate: 4. 50l/min, fio2:53. 9%. At 11:12, pao2 368. 4mmhg. Considering that fio2 at 8:42 was 89. 8% and pao2 at 8:45 was 223. 6mmhg, it is assumable that that gas transfer of the actual sample had been obstructed due to some factors. Based on the findings, it is likely that svo2 decreased due to increasing o2 consumption volume caused by the patient's metabolism having been activated by the rewarming. In addition, gas transfer might have been obstructed due to some factor. Ifu states: measure blood gases and make necessary adjustments as follows. Control pao2 by changing concentration of oxygen in ventilating gas using gas blender. To decrease pao2, decrease fio2. To increase pao2, increase fio2. Start gas supply with v/q
1 and fio2
100%, then make adjustments based on blood gas measurements. Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patient's metabolism. Failure to adjust the gas supply and the blood flow rate appropriately may cause insufficient o2 supply needed or the amount of the patient's gaseous metabolism. A phenomenon called wet lung may occur when water condensation occurs inside fibers of microporous membrane oxygenators with blood flowing exterior to the fibers. This may occur when oxygenators are used for a longer period of time. If water condensation and/or a decrease in pao2 and/or an increase in paco2 is noted during extended oxygenator use, briefly increasing the gas flow rate may improve the performance. Increase gas flow rate, to 20 l/min for 10 seconds. Do not repeat this flushing technique, even if oxygenator performance is not improved. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. The investigation results verified the returned sample was of the normal product. It is likely that water drops were generated due to the wet lung phenomenon, resulting in preventing the gases from being transferred sufficiently; the fio2 set during the event was insufficient for the patient's o2 consumption, resulting in the decreasing svo2, and then decreasing pao2 accordingly; or the volume of supplied o2 became insufficient for the o2 consumption volume that increased due to the patient's metabolism activated by the rewarming, resulting in a decrease in svo2. However, the exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
Event Description
The user facility reported that there was no problem was observed at the beginning of the procedure with the involved capiox custom pack. The oxygenation performance begun to decrease after five and half hours after the pump was on. The actual sample, after a long time run appeared to not be offering oxygenation performance sufficiently for the patient's physique. The actual sample was changed out. The patient was not harmed. The procedure outcome was not reported.
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Manufacturer (Section D)
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
theresa mussaw
reg. no. 2243441
265 davidson ave suite 320
somerset, NJ 08873
MDR Report Key9664533
MDR Text Key191794028
Report Number9681834-2020-00003
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2020
Device Catalogue NumberCX-XRX25201
Device Lot Number190607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2019
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: 02/04/2020 Patient Sequence Number: 1