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

Catalog Number 0684-00-0567

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2020

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.(b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, an "autofill failure" alarm occurred.The patient is in the ccu (coronary care unit) and the customer called for assistance.The helium tank had been already replace and received the same message.The autofill and drain ports were in the correct position.Safety disc in the 12 o'clock position.No blood was observed in the helium tubing.They were advised to remove the helium tank and walked them through steps to reconnect the tank.The alarm message remains.The physician had arrived and made the call to remove the catheter as they were going to remove later in the day.There was no reported injury to the patient.

Manufacturer Narrative

The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.Complaint # (b)(4).

Event Description

It was reported that during intra-aortic balloon (iab) therapy, an "autofill failure" alarm occurred.The patient is in the ccu(coronary care unit) and the customer called for assistance.The helium tank had been already replace and received the same message.The autofill and drain ports were in the correct position.Safety disc in the 12 oclock position.No blood was observed in the helium tubing.They were advised to remove the helium tank and walked them through steps to reconnect the tank.The alarm message remains.The physician had arrived and made the call to remove the catheter as they were going to remove later in the day.There was no reported injury to the patient.

Event Description

It was reported that during intra-aortic balloon (iab) therapy, an "autofill failure" alarm occurred.The patient is in the ccu(coronary care unit) and the customer called for assistance.The helium tank had been already replace and received the same message.The autofill and drain ports were in the correct position.Safety disc in the 12 o'clock position.No blood was observed in the helium tubing.They were advised to remove the helium tank and walked them through steps to reconnect the tank.The alarm message remains.The physician had arrived and made the call to remove the catheter as they were going to remove later in the day.There was no reported injury to the patient.

Manufacturer Narrative

The product was returned with the membrane completely unfolded with blood on the exterior of the catheter and between the returned maquet sheath and the catheter.The extracorporeal tubing and sensor cable were cut at approximately 8.4cm & 7.9cm from the rear of the y-fitting respectively.The cut pieces were not returned.Two catheter tubing kinks were observed at approximately 59cm & 74.4cm from the iab tip.An underwater leak test of the balloon, catheter tubing and y-fitting was performed and no leaks were detected.The iab was placed on the cs300 pump and pumped for two hours which represents one complete autofill cycle.The iab pumped normally and no alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.However, kinks can cause difficulty filling the iab.We were unable to duplicate the clinical settings.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.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: 10255331
• MDR Text Key: 198349854
• Report Number: 2248146-2020-00346
• Device Sequence Number: 1
• Product Code: DSP
• 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,Followup
• Report Date: 08/14/2020

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: 03/13/2019
• Device Catalogue Number: 0684-00-0567
• Device Lot Number: 3000091785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/09/2020
• Supplement Dates Manufacturer Received: 07/13/2020; 08/14/2020
• Supplement Dates FDA Received: 08/04/2020; 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 65