MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number FX 15

Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 04/23/2017

Event Type  malfunction  

Event Description

Upon initiation of bypass, the perfusionist could not achieve calculated full flow.  she spoke to the surgeon and anesthesiologist about the difficulty in achieving flow.  her rpm's on the device were max out.  she called her backup to help her and possibly change the oxygenator out.  she did not have high line pressure so the issue was within the oxygenator.  she also felt the line going into the oxygenator and felt the pressure going in was very high.  however, as they were troubleshooting and contemplating changing the oxygenator, the flow continued to improve.  the decision was made by the perfusionist and surgeon to continue to use this oxygenator vs the risk of changing it out.Lot# vc 13.  patient did well.

• Brand Name: CAPIOX
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball rd.; elkton MD 21921
• MDR Report Key: 6743689
• MDR Text Key: 81060531
• Report Number: 6743689
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2017,06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FX 15
• Device Lot Number: VC 13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR