MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Device Contamination with Body Fluid (2317); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 08/16/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed. There were no non-conformances in the production dhr related to the reported event. A getinge field service engineer (fse) was dispatched to investigate the report of a blood back event. Upon evaluation of the iabp, the fse observed blood in the unit and no failure was identified. The fse replaced the following components due to blood contamination: reservoir assembly, purge valve assembly, condensation removal module (crm) english, safety disk assembly english and iabp blood detect tubing. Full functional and safety tests were performed and the iabp unit passed all functional and safety checks per factory specifications. The iabp was returned to the customer and cleared for clinical use. The full name of the initial reporter is (b)(6).

Event Description

It was reported by the nurse in the coronary icu that earlier in the day the patient had a cardiac arrest. The staff noted that the intra-aortic balloon (iab) had blood in the helium tubing that may have entered the intra-aortic balloon pump (iabp). The staff removed the iab and pulled the iabp from service. The pump was sent to the biomed without knowledge as to whether service is needed. There was no reported malfunction of the iabp. The iab used during this event has been reported under mfg report number (b)(4).

• Brand Name: CS300
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8977626
• MDR Text Key: 158713592
• Report Number: 2249723-2019-01442
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 09/09/2019 Patient Sequence Number: 1