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

Catalog Number 0684-00-0293

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2019

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 use on a patient post insertion of the intra-aortic balloon (iab), the cs300 intra-aortic balloon pump (iabp) experienced an autofill failure.The end user troubleshot the iabp unit and noted that the helium cylinder was more than half full and correctly positioned.The helium tubing was checked between the patient and the iabp unit and it was noted that there was no visible reason for the cause of the alarm.Manual inflation of the iab was performed under fluoroscopy and the expansion of the iab was observed and there was no visible disconnection of the tubing.The end user was unable to initiate an autofill.It was reported that the patient was supported with inotropes and vasopressors and the iab was removed to avoid immobility complications a half hour after insertion.No patient harm or death was reported, but we are attempting to get information on the patient outcome.

Manufacturer Narrative

Updated sections: b4, d1, d4, g4, g5, g7, h2, h4, h6, h10.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 # (b)(4).

Event Description

It was reported that during use on a patient post insertion of the intra-aortic balloon (iab), the cs300 intra-aortic balloon pump (iabp) experienced an autofill failure.The end user troubleshot the iabp unit and noted that the helium cylinder was more than half full and correctly positioned.The helium tubing was checked between the patient and the iabp unit and it was noted that there was no visible reason for the cause of the alarm.Manual inflation of the iab was performed under fluoroscopy and the expansion of the iab was observed and there was no visible disconnection of the tubing.The end user was unable to initiate an autofill.It was reported that the patient was supported with inotropes and vasopressors and the iab was removed to avoid immobility complications a half hour after insertion.No patient harm or death was reported, but we are attempting to get information on the patient outcome.

Event Description

It was reported that during use on a patient post insertion of the intra-aortic balloon (iab), the cs300 intra-aortic balloon pump (iabp) experienced an autofill failure.The end user troubleshot the iabp unit and noted that the helium cylinder was more than half full and correctly positioned.The helium tubing was checked between the patient and the iabp unit and it was noted that there was no visible reason for the cause of the alarm.Manual inflation of the iab was performed under fluoroscopy and the expansion of the iab was observed and there was no visible disconnection of the tubing.The end user was unable to initiate an autofill.It was reported that the patient was supported with inotropes and vasopressors and the iab was removed to avoid immobility complications a half hour after insertion.No patient harm or death was reported, but we are attempting to get information on the patient outcome.

Manufacturer Narrative

Updated sections: b4, d10, g4, g7, h2, h6, h10.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 # (b)(4).

• Brand Name: MEGA 7.5FR. 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 9569915
• MDR Text Key: 188207169
• Report Number: 2248146-2020-00015
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K120868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2020
• Device Catalogue Number: 0684-00-0293
• Device Lot Number: 3000046806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention