MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA 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 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Udi - n/a as this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - clinical engineer.Pma/510(k): k130520.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The manufacturing record and the shipping inspection record of the actual sample found no anomaly.No other similar report with the product of the involved product code/lot number was found.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the capiox custom pack involved was used for open heart surgery.Approximately five (5) hours after the pump started, the removal of carbon dioxide gas started to deteriorate.Since the surgery was nearing completion, the product was used without replacement, and it was detached from the patient.The event occurred intra-operative.There was no patient injury/medical or surgical intervention today.The procedure outcome was not reported.The final patient impact was not harmed.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.Visual inspection of the actual sample upon receipt found no anomaly such as a breakage.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: 386ml/min., @4l/min: 276ml/min.[co2 removal volume] @6l/min: 343ml/min., @4l/min: 247ml/min.The manufacturing record and the shipping inspection record of the actual sample no anomaly was found.No other similar report with the product of the involved product code/lot number was found.It was found that the circulating temperature (venous temperature: approximately 22°c) was low during the period when pco2 was high.Based on the investigation result, the gas transfer performance of actual sample after rinsing met the factory's specifications, and no anomaly was found in the manufacturing records.As a possible cause of occurrence, it was inferred that since the event occurred when the blood temperature was low, it was difficult to remove co2 (the lower the blood temperature, the easier it was to dissolve co2 i.E., the more difficult it was to remove).However, since no anomaly was found in the actual sample after rinsing, the cause of occurrence 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.(warning)".

• Brand Name: CAPIOX CUSTOM PACK
• Type of Device: OXYGENATOR, 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: gina digioia ; reg. no. 2243441; 265 davidson ave suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16131507
• MDR Text Key: 308867479
• Report Number: 9681834-2022-00275
• 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,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CX-XRX63201A
• Device Lot Number: 220315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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