MAUDE Adverse Event Report: GETINGE / DATASCOPE CORP. SENSATION PLUS 7.5 FR. & 8FR. IA; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number 0684-00-0576

Device Problems Loose or Intermittent Connection (1371); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Dyspnea (1816); Failure of Implant (1924); Paresis (1998); Tachycardia (2095); Dizziness (2194); Diminished Pulse Pressure (2606)

Event Date 10/14/2022

Event Type  malfunction  

Event Description

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.X-ray 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).

• Brand Name: SENSATION PLUS 7.5 FR. & 8FR. IA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): GETINGE / DATASCOPE CORP.
• MDR Report Key: 15732480
• MDR Text Key: 303174745
• Report Number: MW5113065
• Device Sequence Number: 1
• Product Code: DSP
• 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: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 0684-00-0576
• 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
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Hispanic
• Patient Race: White