MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO PERFUSION PACK PERFUSION PUMP PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number Z42973699

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/06/2022

Event Type  Death  

Event Description

During extraction of right pacer lead, multiple adhesions were creating difficulty to remove; cardiologist soon perforated through the right atria.Cvt surgeon noticed blood pressure dropping quickly.Cardiologist remained in case to assist cvt surgeon and immediate open procedure began.The perfusion pump was prepared with application of pump pack terumo pack lot # z42973699.Arterial/aortic cannula was placed.The right atrium was cannulated, lower flow saline initiated through arterial cannula lines.Venous cannula placed.Next a larger volume (blood) started to flow through the tubing to the arterial cannula, and the tubing pops apart.Estimated blood loss of 200ml is released.Blood was rapidly infused and cvt surgeon was performing open massage to maintain blood pressure.As soon as pump was started, we went on bypass perfusionist immediately reconnects tubing.Estimated less than 30 seconds to reconnect.Heart was beating fairly well, however we required bypass to reinfuse; but bleeding was so severe we needed to keep bypass on keep reinfusing, but bleeding soon became unmanageable and resuscitation became irreversible, patient soon expired.Fda safety report id # (b)(4).

• Brand Name: TERUMO PERFUSION PACK PERFUSION PUMP PACK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
• MDR Report Key: 13257999
• MDR Text Key: 283823333
• Report Number: MW5106668
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: Z42973699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Hispanic
• Patient Race: White