MAUDE Adverse Event Report: DATASCOPE MAHWAH CARDIOSAVE; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Inability to Auto-Fill (1044)

Patient Problem Chest Tightness/Pressure (2463)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.(b)(4) was not requested in connection with this event.A supplemental report will be submitted if additional information is made available.

Event Description

It was reported that a patient was experiencing continued chest pressure and the cardiosave intra-aortic balloon pump (iabp) was initiated for coronary perfusion and transfer for bypass.However, ¿autofill failure¿ occurred on the iabp during use with a 50cc sensation balloon.The customer stated that all the on-screen instructions were followed, but this did not resolve the issue; customer then switched to a 40cc balloon catheter and the iabp functioned properly.

Event Description

It was reported that a patient was experiencing continued chest pressure and the cardiosave intra-aortic balloon pump (iabp) was initiated for coronary perfusion and transfer for bypass.However, ¿autofill failure¿ occurred on the iabp during use with a 50cc sensation balloon.The customer stated that all the on-screen instructions were followed, but this did not resolve the issue; customer then switched to a 40cc balloon catheter and the iabp functioned properly.No patient harm or serious injury was reported.

• Brand Name: CARDIOSAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 8233638
• MDR Text Key: 133855745
• Report Number: 2249723-2019-00059
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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 Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 01/11/2019
• Supplement Dates FDA Received: 02/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 66