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

Catalog Number 0684-00-0575

Device Problems Optical Problem (3001); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cs300 intra-aortic balloon pump (iabp) generated fiber optic sensor failure and no pressure source messages and stopped pumping.Removing and reinserting the fiber optic (fo) sensor did not resolve the failure alarm.The getinge representative instructed the customer to unplug the fo sensor and transduce the inner lumen to the iabp.The patient was hemodynamically stable.They eventually found a pressure cable and connected it to the iabp and transducer.They leveled and zeroed the transducer and restarted the iabp successfully.There was no patient harm or adverse event reported.

Manufacturer Narrative

Complete initial reporter information: (b)(6).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).

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: 18426416
• MDR Text Key: 331906273
• Report Number: 2248146-2024-00001
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000321167
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CS300
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 81 KG