MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-3023-53

Device Problems Backflow (1064); Device Contamination with Body Fluid (2317)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

Event Type  malfunction  

Event Description

It was reported that during a preventative maintenance (pm) service repair performed by a getinge field service engineer (fse), he noticed the cs300 intra-aortic balloon pump (iabp) had blood in the drain port tubing which reached to the vacuum reservoir.There was no patient involvement, and no adverse event reported.

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: demetris blizzard, phone: (b)(6).Testing of actual/suspected device: enter investigation findings during a preventative maintenance (pm) service, the getinge field service engineer discovered that there was blood in the drain port tubing which reached to the vacuum reservoir.To fix the issue the fse replaced the blood contaminated parts cable clamp, blood detect, iabp, 10-32x1/16 hose barb 5/16 hex , brkt fill manifold, assy crm assy, safety disk, fill manifold assy iabp, pneu component m luer 1/16tb, fill manifold assy, iabp.Performed a complete pm with full calibration, functional testing and safety check to factory specifications and unit passes all functional and safety checks and is ready for patient use.A supplemental report will be submitted upon completion of our investigation.

Event Description

N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13725424
• MDR Text Key: 288821448
• Report Number: 2249723-2022-00498
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: 10607567107882
• Combination Product (y/n): N
• PMA/PMN Number: K063525
• 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,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1