MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number PRODUCT NOT IN LIST - IABP

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  Injury  

Event Description

It was reported by medwatch report received, stating that intra-aortic balloon pump (iabp) unit alarm went off in the patients room.The patient was found to be sitting in his recliner chair and was alert and oriented.The alarm indicated gas loss, then the low augmentation alarm sounded.A repeat chest x-ray was done to make sure everything is where it should be and the x-ray confirmed that placement was correct.The iabp unit was still in place during this time.Upon thorough inspection there was found to be moderate condensation.In addition, all connections were nicely secured, except the right abdomen, the stat- lock/ securement device had come undone as it was being replaced.The patient began to complain about dizziness and appeared like he was going to pass out.Vitals were taken and were at his baseline except his oxygen saturation which dropped to 92%.The patient was asked what symptoms he was experiencing but he appeared to be aphasic and gave 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 oriented x 4.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 a hold of x-ray tech even after multiple attempts to page them.Patient taken to computed tomography and then to cath lab.The balloon failed.Medwatch # (b)(4).

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

It was stated in the medwatch report that the unit was not available for evaluation.A supplemental report will be submitted if additional information is received.Not returned to manufacturer.

• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 15849868
• MDR Text Key: 304175576
• Report Number: 2249723-2022-03006
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRODUCT NOT IN LIST - IABP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 7.5 FR. & 8 F4. IA
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 109 KG