MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION HOLLOW FIBER OXY WITH 3000 ML BLOOD GAS OXYGENATOR

Model Number 3CX*RX15RW30

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the device for evaluation; therefore, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available. For this reason, terumo references evaluation conclusion code (b)(4). Component code #1: (b)(4): reservoir. Component code #2: (b)(4): filter. Health effect: impact code: (b)(4) no patient involvement. Health effect: clinical code: (b)(4): no clinical signs, symptoms or conditions. Medical device problem code: (b)(4): coagulation in device or device ingredient. Investigation findings: (b)(4): results pending completion of investigation. Investigation conclusions: (b)(4): conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, the oxygenator reservoir got clot while priming with blood. De-foaming chamber and screen filter of reservoir got clot resulting in decrease of dynamic volume ( level) while circulating and air came in the circuit. As per the clinical specialist, additional information form the facility states that, 1 unit of blood were put into the reservoir and a blood filter was used in the units of blood when it was put into the reservoir. It is unknown as to what the level of anticoagulation was of the blood introduced to the reservoir and how much heparin was put in the pump prime. Blood is going to clot whenever is contacts any foreign surface if it is not adequately anticoagulated. *no patient involvement *product was changed out prior to cpb during blood priming *procedure was completed successfully.

• Brand Name: HOLLOW FIBER OXY WITH 3000 ML
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): SAME
• Manufacturer Contact: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 12452724
• MDR Text Key: 270812756
• Report Number: 1124841-2021-00214
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450127
• UDI-Public: (01)00699753450127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 3CX*RX15RW30
• Device Catalogue Number: N/A
• Device Lot Number: YA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 10/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial