MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-58
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate the iabp and confirmed blood in the unit and needs to replace the safety disk, crm assembly, blood detect tubing, purge valve assembly, fill manifold assembly, bracket fill manifold, transducer block assembly, male luer, polyurethane tubing, reservoir assembly, barb hose fitting, cable clamp, and the insulator drive manifold.Additional information is being requested with regard to the repair and status of the iabp.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) had a blood stop error.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, g7, h2, h4, h6, h10, h11 corrected fields: d5, e3 a getinge field service engineer (fse) was dispatched to investigate the issue.To fix the issue, the fse located the affected parts due to the blood back and replaced them.The fse then adjusted the unit and verified that the unit was functioning correctly.The fse also confirmed the unit was returned to the customer in cleared for clinical use.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, SPANISH, 220V
• Common Device Name: 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: 14208283
• Report Number: 2249723-2022-00930
• Device Sequence Number: 1841522
• Product Code: DSP
• UDI-Device Identifier: 10607567107622
• UDI-Public: 10607567107622
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3013-58
• Device Catalogue Number: 0998-00-3013-58
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown