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

Model Number N/A

Device Problems Pumping Stopped (1503); Output Problem (3005); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and found that the unit had no initial start-up errors.The fse could not duplicate any initial shutdown failure during pre-testing.The fse checked the fault/error logs and noted codes 111 and 112 were present.To address the logged errors, the fse opted to replace the executive processor board.Full calibration and functional checkout were performed, and the iabp unit was rolled around while under simulation.The error logs were checked once again and no further issues were found.The iabp unit was then cleared for clinical use.(b)(6).

Event Description

It was reported that while a patient was receiving therapy on a cardiosave intra-aortic balloon pump (iabp) on 1:1 observation, an alarm sounded, pumping stopped and the screen froze.The user could not "reiniate" pumping on the iabp by pressing the start button; and cardiopulmonary bypass was initiated immediately, as the patient was heparinized and cannulated.The iabp unit was turned off and then back on, and no alarms occurred.The gas pressure tracing was leveled, about mid balloon and no blood was noted in the balloon catheter connector.The unit was then turned off and switched out with another cardiosave unit, which started uneventfully with no alarms.The faulty unit was removed from service and taken to the bioengineering department.At this time, there is no information that the alleged malfunction caused or contributed to any change in the patient's condition that would be considered a reportable serious injury.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 8035024
• MDR Text Key: 126532790
• Report Number: 2249723-2018-01904
• Device Sequence Number: 0
• Product Code: DSP
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention