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

Catalog Number 0998-00-0800-XX

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 02/14/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was unable to be reviewed as we were not able to obtain the serial number for the iabp associated with this complaint.Additional information has been requested from our local business unit in (b)(4), and will be provided upon receipt.

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy on an ami patient a calibration error occurred and the cardiosave iabp stopped pumping.Attempts were made to restart the iabp but the button was not responding due to the monitor being frozen.Eventually the iabp did reboot and started pumping normally.No patient harm or adverse event was reported.

Manufacturer Narrative

(b)(4).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) evaluated the iabp and was unable to reproduce the reported malfunction.However, the fse replaced the coil code ,safety disk and li-ion battery.The fse then performed running test without occurring any problem.The iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that during intra-aortic balloon pump (iabp) therapy on an ami patient a calibration error occurred and the cardiosave iabp stopped pumping.Attempts were made to restart the iabp but the button was not responding due to the monitor being frozen.Eventually the iabp did reboot and started pumping normally.No patient harm or adverse event 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
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 7317373
• MDR Text Key: 101846834
• Report Number: 2249723-2018-00349
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2013
• 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