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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX CUSTOM PACK OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-XRX51804
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2021
Event Type  malfunction  
Event Description
The user facility reported that the capiox custom pack was used during a major vessel replacement surgery, about twenty minutes after the start of cooling, the blood gas was measured and the pco2 was found 67. Although the gas flow was increased to cope with it, pco2 remained high even during cerebral perfusion. After rewarming was started, co2 was able to be removed without any problems. The patient was not harmed. The procedure outcome was not reported.
 
Manufacturer Narrative
(b)(6). Udi - not required for product code. Implanted date: device was not implanted. Explanted date: device was not explanted. Occupation- clinical engineer. Pma/510(k)- k130520. The actual sample was received for evaluation. Visual inspection revealed no breakage or other anomaly in the appearance. The actual sample was rinsed with normal saline flowed by head, and then the oxygenation module was inspected visually. Formation of blood clots was not observed. The actual sample after rinsed and dried was tested for its gas transfer performance in accordance with the factory's inspection protocol. As a result, the obtained values met the factory specifications, and no anomalies were revealed. [bovine blood conditions] hb:12g/dl, temp. : 37°c. , ph:7. 4, svo2:65%, pvco2: 45mmhg. [circulation conditions] blood flow rate: 6l/min and 4l/min, v/q
=
1, fio2
=
100%. [o2 transfer volume] @6l/min
=
366 ml/min. @4l/min
=
260 ml/min. [co2 removal volume] @6l/min
=
316 ml/min. @4l/min
=
236 ml/min. Review of the provided pump record revealed: at 11:27 when paco2 was 67 mmhg, the circulation condition was as follows. Blood flow rate
=
4. 17 l/min and gas flow rate
=
2. 0l/min. The arterial blood temperature
=
14. 0°c, which was the lowest temperature throughout this procedure. 13:10 when rewarming started, paco2 was 34. 7 mmhg, blood flow rate
=
1. 12 l/min, gas flow rate
=
8. 5 l/min, and arterial blood temperature
=
36. 6°c. From 11:27 until 13:10, pao2 was maintained over 382mmhg and did not tend to decrease. As it was pointed out, paco2 increased while the arterial blood temperature was low, but pao2 did not decrease. Therefore, the increase in paco2 was considered to be due to the arterial blood temperature. A review of the device history record and product-release judgement record of the involved product code/lot# combination was conducted with no findings. Ifu states: measure blood gases and make necessary adjustments as follows. B. Control paco2 by changing the total gas flow. To decrease paco2, increase total gas flow. To increase paco2, decrease total gas flow. 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 normal product. The reason for the increase in paco2 during the low arterial blood temperature is conceivable that the low blood temperature made co2 easily soluble in the blood, i. E. , co2 was difficult to remove. The exact cause of the reported event cannot be definitively determined based on the available information. (b)(4).
 
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Brand NameCAPIOX CUSTOM PACK
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, 418
JA 418
Manufacturer Contact
mary o'neill
reg. no. 2243441
265 davidson ave suite 320
somerset, NJ 08873
8002837866
MDR Report Key12802271
MDR Text Key282208218
Report Number9681834-2021-00191
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071494
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCX-XRX51804
Device Lot Number210702
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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