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

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The user facility reported that the patient's bsa: 1.9m2, and the blood flow rate: 4.8l/min.From approximately 180minutes after the start of circulation, the gas transfer performance gradually decreased.Oxygen flow rate: 2 l and fio2: 0.6 finally increased to oxygen flow rate: 5 l and fio2: 1.0, and managed to complete the procedure in 340 minutes.The oxygen flow rate and fio2 were increased, and since occurrence of wet lung was also suspected, several gas flushes were performed at 10l/30sec.It was repeatedly stopped and recirculated, and then frequent inspection of act was performed and cdi data was checked.A new product was prepared to replace the oxygenator.Postoperative confirmation revealed no particular problems with blood clots.In addition, no intraoperative plasma leak was confirmed.The procedure outcome was not reported.The patient was not harmed.

Manufacturer Narrative

D4: udi no: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: clinical engineer.G4: 510(k) no: k071494, k130520.1.Investigation of the actual sample: 1.1.Visual inspection of the actual sample upon receipt.No anomaly such as a breakage was found.1.2.After rinsing and drying the actual sample, the amount of oxygen transfer and carbon dioxide gas removal were measured according to the product inspection procedure.They met the factory's specifications.No anomaly was found.[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: 380ml/min., @4l/min: 275ml/min.[co2 removal volume] @6l/min: 326ml/min., @4l/min: 234ml/min.2.Record review: 2.1.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found.2.2.Past complaint file.No other similar report of the product with the involved product code/lot# was found.2.3.Manufacturing date: april 4, 2023.2.4.Confirmation of the pump record.The patient's height: 173cm, weight: 77kg, and bsa: 1.91m2.Extracorporeal circulation was started at 10:28.Blood gas data at 10:39, when the blood flow rate began to stabilize, was po2: 282mmhg.The circulation conditions at this time were the blood flow rate: 4.82l/min, the gas flow rate: 1.9l/min, and fio2: 0.6.Then, po2 transited at approx.300mmhg, but decreased to 124mmhg at 13:49.After that, po2 increased temporarily, but po2 decreased to 113mmhg at 14:09.In addition, it was confirmed that the blood flow rate was 0 during the period when po2 decreased, and that it was repeatedly stopped and recirculated.The relationship between po2 and fio2 was confirmed.Fio2 was increased from 0.6 to 0.7 at 14:27, and after increasing fio2, po2 tended to increase at 14:27 and 15:09.However, since this period was also the timing of resumption of circulation, it was not possible to determine whether the increase in fio2 affected the increase in po2.3.Cause of occurrence/conclusion: based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found.As a possible cause of occurrence, it was inferred that for fio2 at the time of use, the oxygen supply amount was insufficient for the patient's metabolism.However, since no anomaly was found in the actual sample after rinsing, the cause of this case could not be clarified.Relevant instructions for use (ifu) reference: "start gas supply with v/q=1, and fio2=100%, then make adjustments based on blood gas measurements.Measure blood gases and make necessary adjustments as follows.A.Control pao2 by changing concentration of oxygen in ventilating gas using gas blender.-to decrease pao2, decrease fio2.-to increase pao2, increase fio2.B.Control paco2 by changing the total gas flow.-to decrease paco2, increase total gas flow.-to increase paco2, decrease total gas flow.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.Upon patient rewarming, adjust o2 concentration, gas flow rate and blood flow rate by increasing them as needed based on an increase in patients 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." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• Brand Name: CAPIOX CUSTOM PACK
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17516021
• MDR Text Key: 321141994
• Report Number: 9681834-2023-00157
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071494
• Number of Events Reported: 1
• 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: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX46501
• Device Lot Number: 230404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2023
• 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