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

Model Number 0684-00-0576-01

Device Problems Difficult to Flush (1251); Material Deformation (2976); Optical Problem (3001)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the cardiosave intra-aortic balloon pump (iabp) generated a catheter restriction.They could resume pumping, but only for a few seconds.There was no visible blood in the tubing, but there was an acute kink near the insertion site and the customer stated that the patient was very noncompliant with keeping still.The patient was constantly moving the leg and confused.They were advised to obtain a chest film, and attempt to straighten the kink if possible.Also suggested the "fill" key but this only lasted a few seconds before alarming again.Suggested a drop in the augmentation, and this worked for the remainder of the call.A chest film has been ordered, and they will try to straighten the tubing near the insertion site.Approximately 30 minutes later, at 0510, the customer called back to report a fiber optic sensor failure message, but that the restriction alarm had subsided.They were able to increase the augmentation during that time and it had not alarmed again.Advised them to disconnect the fiber optic and consider an alternate arterial line.The patient had no other arterial line, and the iab central lumen would not aspirate or flush.They planned to contact the md about arterial line placement.At 0624, the customer called back to state that they obtained an arterial line, zeroed and now had a waveform and pressure but the pump now generated gas loss in iab circuit and catheter restriction alarms.They could resume pumping with the augmentation control down 4 bars, but only for a short time.The patient continued to be restless and moving about.They were advised to speak to a physician about considering adjusting the iab or removal/replacement as they were unable to continue pumping.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.Complaint record id # (b)(4).

Event Description

N/a.

Manufacturer Narrative

The device has not been returned to the manufacturer so we are unable to complete an evaluation.Reference complaint #: (b)(4).

• 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: 16277987
• MDR Text Key: 308918705
• Report Number: 2248146-2023-00073
• 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: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000270586
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 147 KG