MAUDE Adverse Event Report: LIVA NOVA / CARDIAC ASSIST, INC. LIFESPARC PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Catalog Number 5820-3118

Device Problems Fluid/Blood Leak (1250); Inadequate Instructions for Healthcare Professional (1319); Loose or Intermittent Connection (1371); Use of Device Problem (1670)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/20/2022

Event Type  Injury  

Event Description

The outlet tubing on lifesparc pump appeared normal on friday ((b)(6) 2022) when we first ambulated our patient with the voyager vest.The bedside rn called noting blood dripping out of the outlet area saturday ((b)(6) 2022) morning.Our team was able to assess.Tubing had migrated off the second outlet barb and was just making full contact with the first outlet barb.She was able to get the outlet tubing advanced back up to the second barb and secured with a zip tie and banding gun (she secured the inlet tubing as well, just to be safe).Tubing appears to be holding with no movement when i checked on our patient today.Implant date: (b)(6) 2022 ¿ pump on at 14:30 event date: (b)(6) 2022 ¿ noted by day shift bedside rn when taking over at shift change ~7:30 am pdt pump, sn: (b)(4).This is a new product to our facility.We had product training by liva nova clinical consultant on (b)(6) 2022.In this training, the need to zip tie connections to prevent egress of tubing was not mentioned.Following the event, company was notified.Initial response by clinical consultant was that the chief engineer stated that tubing should be bonded and that this was a device error which would be followed up on.Following responses over the next few days revealed that the updated directions for use (dfu) for the pump specify that connections should be secured with zip ties.However, the dfu we had from initial placement 9 days before this event did not include this recommendation, and we were not trained to this new practice in the dfu on (b)(6) 2022 nor notified of updated dfu.Fda safety report id# (b)(4).

• Brand Name: LIFESPARC PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVA NOVA / CARDIAC ASSIST, INC.
• MDR Report Key: 14592931
• MDR Text Key: 293379367
• Report Number: MW5110074
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2023
• Device Catalogue Number: 5820-3118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM-(B)(6) 2021-(B)(6) 2021-(B)(6) 2022
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Hispanic
• Patient Race: White