MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 8FR. 50CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0576-01

Device Problems Gas/Air Leak (2946); Pressure Problem (3012)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Dyspnea (1816); Paresis (1998); Tachycardia (2095); Dizziness (2194); Diminished Pulse Pressure (2606)

Event Date 11/01/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint record id # (b)(4).

Event Description

The following was reported via (b)(4).Received on (b)(6) 2022: intra-aortic balloon pump iabp pump alarm went off in my patient's room, upon arrival i found the patient sitting in his recliner chair with family at bedside, patient was alert and oriented.The alarm indicated gas loss and right after the low augmentation alarm went off; nurse practitioner was informed and was asked if she wanted to repeat x-ray to make sure it was still in the right place.Xray done, iabp was still in the right place.I couldn't find where the helium gas could be leaking out of, only moderate condensation noted upon thorough inspection.In addition, all connections were nicely secured, except the right lower abdomen, the stat-lock/securement device had come undone, as i was replacing it, patient started complaining of dizziness, he appeared like he was going to pass out, when i looked at his vitals, all were within his baseline, except for his o2 sat had dropped to 92%, i asked him what other symptoms he was experiencing, but patient appeared to be aphasic, he gave me a blank stare with no verbal response.Patient was still alert, airway was patent, breathing slightly tachypneic, with a thready pulse, (a change from previous assessment as it was 2+).In addition, upon assessing his extremities for weakness, i realized he couldn't move any of his right sided extremities.I immediately asked a fellow nurse to call the team and to call code stroke.Stroke team, and other fellow employees at bedside assisting patient.Upon re-assessment patient was able to slowly communicate and we were able to determine he was orientedx4.Patient appeared anxious and fearful as he could feel "something [was] wrong" as stated by the patient.Patient started going into vtach, and began c/o chest pain, left sided shoulder and abdominal pain, crash cart at bedside, oxygen administered through a nasal cannula, new iv placed and labs drawn, amiodarone bolus given.Team requesting repeat x-ray, before heading to computed tomography, but we were unable to get ahold of x-ray tech even after multiple attempts to page them.Patient taken to computed tomography and then to cath lab.The balloon failed.Fda safety report id #(b)(4).This report is for the iab.A separate report has been submitted for the iabp under mfg report number 2249723-2022-03006.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #: (b)(4).

Event Description

N/a.

• Brand Name: SENSATION PLUS 8FR. 50CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ
• Manufacturer Contact: brian schaeffer ; 15 law drive; fairfield, NJ
• MDR Report Key: 15890168
• MDR Text Key: 304590543
• Report Number: 2248146-2022-00938
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN PUMP.
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 108 KG