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

Catalog Number 0998-00-0800-53

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 01/30/2018

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 the company standard operating procedure since the device manufacture date is greater than one year from the event date. Getinge service has not been requested at this time. Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had an abnormal waveform resulting in abnormal readings. Nothing had changed with the patient, all connections were checked. The iabp had been running for approximately 48 hours. The customer weaned the patient and disconnected the iabp. It was also reported that the iabp had strange waveforms sometime in the fall. It was advised that no blood was seen in the tube set. No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

The customer reported that the alleged malfunction was a result of a setting error. The iabp has since been used without issue.

Event Description

It was reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) had an abnormal waveform resulting in abnormal readings. Nothing had changed with the patient, all connections were checked. The iabp had been running for approximately 48 hours. The customer weaned the patient and disconnected the iabp. It was also reported that the iabp had strange waveforms sometime in the fall. It was advised that no blood was seen in the tube set. No patient harm, serious injury 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: 7288561
• MDR Text Key: 100917368
• Report Number: 2249723-2018-00278
• 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,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 05/21/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 11/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse