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 Restricted Flow rate (1248); Optical Problem (3001)

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

Event Date 10/07/2023

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: manager.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 during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.The customer explained that the alarm was intermittent and would resolve when they pressed the calibrate pressure button.The getinge representative suggested that they change the console out which resolved the issue temporarily.Later in the evening, the night shift rn, called with the same problem but said the alarm was staying on longer and longer.It was then suggested they switch over to the inner lumen of the catheter.However, it was discovered that the inner lumen was clotted.It was explained that they needed to obtain an alternate pressure source to appropriately time the console.The customer said they would have the provider place a radial line as soon as possible.There was no patient harm or adverse event reported.

Manufacturer Narrative

Updated fields: describe event or problem device available for eval? the device has not been returned to the manufacturer so we are unable to complete an evaluation.Complaint record id # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console generated a fiber optic sensor failure alarm.The customer explained that the alarm was intermittent and would resolve when they pressed the calibrate pressure button.The getinge representative suggested that they change the console out which resolved the issue temporarily.Later in the evening, the night shift rn, called with the same problem but said the alarm was staying on longer and longer.It was then suggested they switch over to the inner lumen of the catheter.However, it was discovered that the inner lumen was clotted.It was explained that they needed to obtain an alternate pressure source to appropriately time the console.The customer said they would have the provider place a radial line as soon as possible.The perfusionist stated he unplugged it and plugged back in and there were no further issues with that same iab.There was no patient harm or adverse event reported.

• 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: 18011300
• MDR Text Key: 326614654
• Report Number: 2248146-2023-00638
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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: 3000289565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 115 KG