MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number CX-XRX45403

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 02/22/2018

Event Type  malfunction  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Pma/510(k-) k130520.The actual device was not returned for evaluation and was discarded by the involved facility, however a photographs of the actual sample were provided.A review of the provided photos showing the actual sample confirmed the customer's complaint.The support arm was noted to have come off.A photograph of the actual reported product code/lot combination kept after the assembling process was reviewed.The support arm was confirmed to be securely fixed to its correct position.Functional testing was conducted.A test sample packed in the shelf box was dropped in free fall from 2-meter high with the bottom side of the box facing to the ground.Subsequently, the box was opened to check the state of the support arm.The support arm was found to have come off the reservoir being similar to the actual sample.A review of the device history record from the reported product code/lot number combination was conducted with no findings.A search of the complaint file found no previous report of this nature with the involved product/lot# combination.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause cannot be determined, based on the investigation it is likely that the actual device was exposed to excessive shock force at some time after the assembling process before being unpacked, resulting in the reported damage.The ifu states: "this device is sterile and non-pyrogenic in the unopened, undamaged package.Inspect the device and package carefully.Do not use if the package and/or device is damaged, or if caps are not in place." (b)(4).

Event Description

The user facility reported that the oxygenator module had been separated from the reservoir in the unopened bag when taking out of the box and was found pre-treatment.The actual device was taken out of the bag and found that the supportive arm had come off the reservoir.It was fixed back to the original state and the device was used.There was no patient involvement.Procedure outcome is unknown.Final patient impact is unknown.

• Brand Name: CAPIOX FX OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 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 ; 8002837866
• MDR Report Key: 7351854
• MDR Text Key: 103091315
• Report Number: 9681834-2018-00031
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: CX-XRX45403
• Device Lot Number: 161006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2016
• 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