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); Failure to Calibrate (2440); Optical Problem (3001); Pressure Problem (3012)

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

Event Date 03/11/2021

Event Type  malfunction  

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

It was reported that during intra-aortic balloon (iab) therapy, the console indicated that it was unable to calibrate the fiber optic sensor.The customer stated that the message appeared earlier when the patient had attempted to get out of bed.There were no other support devices.The cuff pressure was reading in the 90s and the arterial line tracing was erratic with irregular numbers.The customer attempted several calibrations, disconnected, and reconnected with no change.It was noted that the central lumen was slow to flush and would not aspirate.An underlying arterial line waveform was not present using the transducer.The customer was advised to do a chest film and that another arterial line site could work.After the patient's mitral valve surgery, nothing had changed.The physicians were aware of the issue and the console was running off electrocardiogram trigger.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.The failure mode is addressed in the risk file and is operating within its risk profile.The ifu addresses the reported failure.There were no ncmrs identified which could cause or contribute to the reported failure.The investigation does not indicate that the device was inadvertently released as non-conforming or an adulterated product or was a counterfeit.The complaint history review did not identify an adverse trend (increase in number of complaints over past three (3) months).Based on the rational provided above, no escalation to the capa process is required.Reference complaint # (b)(4).H3 other text : device not returned.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, the console indicated that it was unable to calibrate the fiber optic sensor.The customer stated that the message appeared earlier when the patient had attempted to get out of bed.There were no other support devices.The cuff pressure was reading in the 90s and the arterial line tracing was erratic with irregular numbers.The customer attempted several calibrations, disconnected, and reconnected with no change.It was noted that the central lumen was slow to flush and would not aspirate.An underlying arterial line waveform was not present using the transducer.The customer was advised to do a chest film and that another arterial line site could work.After the patient's mitral valve surgery, nothing had changed.The physicians were aware of the issue and the console was running off electrocardiogram trigger.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
• MDR Report Key: 11605576
• MDR Text Key: 244204243
• Report Number: 2248146-2021-00209
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108605
• UDI-Public: 10607567108605
• Combination Product (y/n): N
• PMA/PMN Number: K112327
• 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: 04/28/2021

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: 07/23/2023
• Device Model Number: 0684-00-0576-01
• Device Catalogue Number: 0684-00-0575
• Device Lot Number: 3000128022
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/11/2021
• Initial Date FDA Received: 04/01/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 04/28/2021
• Patient Sequence Number: 1
• Treatment: CARDIOSAVE
• Patient Age: 21 YR
• Patient Weight: 66