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

Catalog Number 0998-00-0800-XX

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Temperature Problem (3022)

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

Event Date 05/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.The getinge representative evaluated the iabp and checked the regulators.He made adjustments and found them to be within acceptable range and all available fans and the compressor was working well.The rep replaced the power management board but a problem still persisted.As of the date of this report the repair of the iabp is on going.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) alarmed system over temperature and error code #3 while in use on a patient.The iabp was swapped out and therapy continued.An attempt was made to try to solve the alleged malfunction by adjusting the regulators rg3/rg4 but the iabp was still alarming.There was no patient injury, harm or adverse event reported.

Manufacturer Narrative

The getinge representative evaluated the iabp later and reported that the compressor temperature sensor was defective.To fix the issue, the service engineer replaced the tidal volume, the temperature sensor, the 9v battery and the safety disk.The iabp was returned to the customer and cleared for clinical use.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) alarmed system over temperature and error code #3 while in use on a patient.The iabp was swapped out and therapy continued.An attempt was made to try to solve the alleged malfunction by adjusting the regulators rg3/rg4 but the iabp was still alarming.There was no patient injury, harm or adverse event 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: 7602787
• MDR Text Key: 111713442
• Report Number: 2249723-2018-01005
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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