MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR PROCEDURE KIT P/N: 74109 REV: 16 A ; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	P/N 74109 REV: 16A
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A (b)(6) male underwent triple coronary artery bypass.The pt's chest was open, the cardioplegic solution was applied to stop the heart, the cross-clamp was applied, and the pt was attached to the cardiovascular tubing on the heart-lung machine, when a low level pump alarm alerted the perfusionist that blood was below the pre-set level of 300 mls in the reservoir.A leak at the outlet port on the oxygenator was identified, and the outlet port was identified as being completely broken off, and the now shortened outlet port was too short to be able to re-connect tubing to it.Attempts were made to initially seal the crack, but did not work.The surgeon hand massaged the heart while the perfusionist exchanged out the broken terumo fx 25 oxygenator with a new one.An emergent blood transfusion of 4 units prbc's and 1 unit platelets was quickly administered through a central line while the oxygenator was being replaced.The heart-lung machine was analyzed by the vendor for livanova, and deemed to be working fine several days later.A complaint was filed with terumo, the mfr of the cardiovascular procedure kit, and put on notice regarding lot # wc 26, and the fx 25 oxygenator (serial number (b)(4)); 6 kits with this lot numbers were sequestered.The defective fx 25 oxygenator, sn (b)(4) will be returned to the mfr on (b)(6) 2018.Fx 25 oxygenator located in kit.

• Brand Name: CARDIOVASCULAR PROCEDURE KIT P/N: 74109 REV: 16 A
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO; ashland MI 01721
• MDR Report Key: 7605226
• Report Number: MW5077875
• Device Sequence Number: 1512388
• Product Code: DTZ
• UDI-Device Identifier: 00699753482616
• UDI-Public: 0100699753482616
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: P/N 74109 REV: 16A
• Device Catalogue Number: (17) 190930 (10) WC26
• Device Lot Number: WC 26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 97