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

Catalog Number 0998-00-0800-53

Device Problem Failure to Calibrate (2440)

Patient Problem No Patient Involvement (2645)

Event Date 01/17/2018

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. The initial reporter named is a getinge employee who has different contact details from that of the event site, and has the following contact information: (b)(6). The getinge service territory manager (stm) isolated the malfunction to the helium reservoir assembly, he replaced it and calibrated the new regulator to specification. The stm then completed a full check out of the iabp and returned it to clinical use.

Event Description

It was reported that during preventative maintenance of the cardiosave intra-aortic balloon pump (iabp) performed by a getinge representative it was observed that the helium regulator was out of calibration and could not be adjusted to specifications. There was no patient involvement 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: 7258496
• MDR Text Key: 99767179
• Report Number: 2249723-2018-00212
• 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

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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: 01/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse