MAUDE Adverse Event Report: DATASCOPE CORP. - FAIRFIELD SENSATION PLUS 7.5FR. 40CC IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0684-00-0568-01

Device Problems Difficult to Flush (1251); Optical Problem (3001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Additional initial reporter: (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).

Event Description

It was reported that after several days of intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.The customer switched to transducing the fluid lumen.There was no patent lumen after attempts at aspirating and flushing.The customer was then advised to insert a radial line.There was no patient harm or adverse event reported.

Event Description

It was reported that after several days of intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.The customer switched to transducing the fluid lumen.There was no patent lumen after attempts at aspirating and flushing.The customer was then advised to insert a radial line.There was no patient harm or adverse event reported.

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.Reference complaint #: (b)(4).

• Brand Name: SENSATION PLUS 7.5FR. 40CC IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 11372219
• MDR Text Key: 233273019
• Report Number: 2248146-2021-00130
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108063
• UDI-Public: 10607567108063
• Combination Product (y/n): N
• PMA/PMN Number: K122628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

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 Expiration Date: 08/20/2023
• Device Model Number: 0684-00-0568-01
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000129252
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 06/11/2021
• Supplement Dates FDA Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CS300; CS300
• Patient Age: 66 YR
• Patient Weight: 53