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.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on september 10, 2021.  upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated by manufacturer - a second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

Manufacturer Narrative

This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information and device evaluation).H6 (identification of evaluation codes 10, 11, 3331, 213, 67).Type of investigation #1: 10 - testing of actual/suspected device.Type of investigation #2: 11 - testing of device from same lot/batch retained by.Manufacturer type of investigation #3: 3331 - analysis of production records.Investigation findings: 213 - no device problem found.Investigation conclusions: 67 - no problem detected.The affected sample was inspected upon receipt with no visual anomalies noted.It was then tested for clotting with bovine blood at 5 l/minute for one hour with 100ml/min air injection with no clotting on the filter observed in the cardiotomy portion of the reservoir.The retention sample from the same lot number was obtained with no visual anomalies noted.It was also tested the same way with no clotting on the filter observed in the cardiotomy portion of the reservoir.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• 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
• 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
• PMA/PMN Number: K151389
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• Device Expiration Date: 12/31/2022
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1