FDA Adverse Event Injury Summary report: N

CARDIOPLEGIA PACK

MDR report key: 20830134 · Received December 3, 2024

Report

Report Number: 1718850-2024-01010
Event Type: Injury
Date Received: December 3, 2024
Date of Event: November 4, 2024
Report Date: December 2, 2024
Manufacturer: LIVANOVA USA INC.
Product Code: DWE
UDI-DI: 00803622142550
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: LA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. H11: LIVANOVA USA INC. MANUFACTURES THE CARDIOPLEGIA PACK. THE INCIDENT OCCURRED IN (B)(6), LOUISIANA. THROUGH FOLLOW-UP COMMUNICATION LIVANOVA LEARNED THAT THE AFFECTED UNIT IS NOT AVAILABLE FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 0

LIVANOVA USA INC. RECEIVED A REPORT RELATED TO AN AIR INGRESS INTO A PERFUSION TUBING SYSTEM (PTS) PACK. IN DETAIL, CARDIOPLEGIA LINE WAS PRIMED AND FLUSHED WITH NO LEAKS NOTED WHEN OVER-PRESSURIZED WHILE IN PRIMING MODE. ONCE CROSS CLAMP WAS ON, WHILE DELIVERING THE CARDIOPLEGIA SOLUTION TO THE PATIENT, THE DELIVERY SYSTEM AND LINE FILLED WITH AIR. DELIVERY WAS THEN STOPPED AND ATTEMPTED TO FLUSH AIR TO THE FIELD. HOWEVER, MORE AIR CAME INTO DELIVERY SYSTEM. THEREFORE, CROSS CLAMP WAS REMOVED. PATIENT WAS DEFIBRILLATED AND CARDIOPLEGIA SYSTEM WAS EXCHANGED FOR NEW ONE. NEW CARDIOPLEGIA CIRCUIT WAS PRIMED AND FLUSHED TO THE FIELD. CROSS CLAMP WAS PLACED AND CARDIOPLEGIA WAS DELIVERED WITH NO AIR ISSUES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1414936	CARDIOPLEGIA PACK	SMART, PERFUSION TUBING PACKS	DWE	LIVANOVA USA INC.		2405900038	00803622142550

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown	Required Intervention