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

Model Number N/A

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 10/03/2018

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 getinge 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 confirmed the reported issue. The fse found that the issue occurred intermittently during testing and replaced the high pressure transducer, high pressure regulator, cart wiring harness and the cart to backplane cable. The iabp unit now displays the helium tank pressure properly on the display screen. Full calibration, functional testing and safety checks were completed and passed to factory specifications. The iabp unit was then cleared for patient use.

Event Description

It was reported that during set up, the helium gauge on the display of the cardiosave intra-aortic balloon pump (iabp) indicated that no helium tank was connected; however, the helium tank was turned on and full. In addition, the pressure gauge on the cart was reading the pressure. There was no patient involvement; thus, no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• 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: 8005740
• MDR Text Key: 125277994
• Report Number: 2249723-2018-01850
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• 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,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse