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

Model Number N/A

Device Problem Pumping Stopped (1503)

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

Event Date 11/24/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A supplemental report will be submitted when subsequent information is provided.(b)(6).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a ¿system over temperature¿ alarm and stopped pumping.The iabp was rebooted and the iabp restarted pumping.Approximately an hour later, the same alarm occurred and stopped pumping again.The customer replaced the iabp with a cs100 iabp to continue therapy.The iab catheter was not replaced.It was noted that a decrease of arterial pressure was seen.It was noted 110mmhg when the augmentation was set, but it was down to 90mmhg when self-inflation was used.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.The fse determined that the cause of the issue was the threaded probe temperature sensor.The fse replaced the temperature sensor to address the issue and opted to replace the scroll compressor as a precautionary measure.The fse continued to perform a preventative maintenance on the iabp unit.The iabp was tested, passed to factory specifications and cleared for clinical service.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a ¿system over temperature¿ alarm and stopped pumping.The iabp was rebooted and the iabp restarted pumping.Approximately an hour later, the same alarm occurred and stopped pumping again.The customer replaced the iabp with a cs100 iabp to continue therapy.The iab catheter was not replaced.It was noted that a decrease of arterial pressure was seen.It was noted 110mmhg when the augmentation was set, but it was down to 90mmhg when self-inflation was used.No patient harm, serious injury or 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
• MDR Report Key: 8184792
• MDR Text Key: 131310264
• Report Number: 2249723-2018-02176
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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
• Date Manufacturer Received: 02/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention