MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15RWC W/ 3L RES; BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RW30C

Device Problem Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

Terumo has received the device for evaluation, however, 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.(b)(4); results: results pending completion of investigation.Conclusions: conclusion not yet available.

Event Description

The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator line pressure had reached 430.As per the subsidiary, the patient has been on bypass for approximately 30 minutes when they noticed the pressure had reached 430.The oxygenator needed to be changed out mid-case.There was a delay for leas than 3 minutes; the product was changed out; 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 october 5, 2020.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.

Event Description

Additional information has been received from the user facility.The patient was in for lvad (left ventricular assist device) and rvad (right ventricular assist device) implant.A roller pump was being used.Patient had dilated cardiomyopathy and no previous exposures to heparin.Initiation of cpb was 27 minutes from the initial dose of heparin.First dose was at 09:20 for 35,000 units and the first act at 09:27 with the value of 345.Second dose of heparin was given at 09:27 for 20,000 units and the act at 09:30 was 573.The act on bypass were: 10:00 = 550, 10:18 = 973, 10:45 = 832, 11:12 = 778, 11:46 = 752, 12:17 = 719.An extra 10,000 units of heparin was given during bypass; however, the heparin levels were not monitored.Patient was off cpb for 33 minutes during the product change out and patient's temperature was at 36 degrees celsius.The venous saturation prior to the product change out was approximately between 68% and 78%, hgb between 95 and 110, and the blood gas values at 10:00 were: hb - 9.5, ph - 7.303, pco2 - 46.4, po2 - 242.5, k - 5.06, hco3 - 22.5, be - 3.8, lactate - 3.28.

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: d4 (additional device information - added exp date), g4 (date received by manufacturer), g7 (indication that this is a follow-up report) , h2 (follow-up due to additional information and device evaluation), h3 (device evaluated by manufacturer), h4 (device manufacture date), h6 (identification of evaluation codes 10, 3331, 213, 67).Method code #1: 10 - testing of actual/suspected device.Method code #2: 3331 - analysis of production records.Results code: 213 - no device problem found.Conclusions code: 67 - no problem detected.The returned sample was visually inspected upon receipt with no anomalies, such as break in the appearance.It was then rinsed, dried, and built into a circuit with tube.Bovine blood was circulated in the circuit, while the pressure drop was determined at each flow rate.The obtained values were confirmed to meet the factory's specifications and no obstruction was confirmed.Review of the manufacturing record and the incoming inspection record of the involved product / lot number combination confirmed there were no indications of anomalies in them.The evaluation result verified that the actual sample after having been rinsed was the normal product presenting no problem.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• Brand Name: STERILE FX15RWC W/ 3L RES
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 10631936
• MDR Text Key: 219177576
• Report Number: 1124841-2020-00229
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450783
• UDI-Public: (01)00699753450783
• 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: 11/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 3CX*FX15RW30C
• Device Catalogue Number: N/A
• Device Lot Number: YC10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1