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

Model Number N/A

Device Problems Connection Problem (2900); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) is not required to be reviewed per getinge standard operating procedure since the iabp was manufactured more than a year before the date of event.A supplemental report will be submitted when additional information is made available.

Event Description

I was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated an "iab disconnect" message on the screen.The balloon lines and helium catheter tubing were traced back and no disconnection was noted.The helium tubing was confirmed to be secure.The end user pushed "start" and the iabp unit continued without issue, but it was noted that at this time, the full helium tank dropped to half.The end user continued to monitor the helium levels for several minutes after continuing therapy and noted that there was no continuation of a drop in helium.No additional messages were noted and the patient transport was competed with the remaining helium.No patient injury or adverse event was reported.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated an "iab disconnect" message on the screen.The balloon lines and helium catheter tubing were traced back and no disconnection was noted.The helium tubing was confirmed to be secure.The end user pushed "start" and the iabp unit continued without issue, but it was noted that at this time, the full helium tank dropped to half.The end user continued to monitor the helium levels for several minutes after continuing therapy and noted that there was no continuation of a drop in helium.No additional messages were noted and the patient transport was competed with the remaining helium.No patient injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue while testing with trainer.The fse replaced the helium fill port o-rings as a precautionary measure and tightened the internal helium fittings.The fse then performed a full calibration,functional and safety checks to meet factory specifications.Unit passed all calibration, functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.

• Brand Name: CARDIOSAVE RESCUE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 9732602
• MDR Text Key: 192062322
• Report Number: 2249723-2020-00284
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

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 Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 02/27/2020
• Supplement Dates FDA Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1