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

Model Number 0998-00-0800-53

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/12/2022

Event Type  malfunction  

Manufacturer Narrative

The initial reporter named is a getinge employee who has different contact details from that of the event site. A contact person at the event site is (b)(6). Testing of actual/suspected device: while completing the preventative maintenance (pm), it was discovered that there was evidence of a previous blood back. It was also discovered that the upper panel assembly had sustained previous damage. The fse completed the repairs in addition to the the full pm, calibration, safety, and functionality checks were completed per the service manual. All checks were passed per the factory specifications. The device is functioning in accordance with factory specifications at this time and is cleared for clinical use. A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge field service engineer (fse) there was noted evidence of a blood back on the cardiosave intra-aortic balloon pump (iabp). There was no patient involvement, and no adverse event was reported.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13455811
• MDR Text Key: 289495345
• Report Number: 2249723-2022-00222
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse