MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-65
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Fitting Problem (2183); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during regular inspection the cs300 intra-aortic balloon pump (iabp) unit pump cannot be fixed to the transport cart due to blood intrusion from rupture.The electrical test fails, and code #50 has occurred.There was no patient involvement reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit and was able to reproduce the reported malfunction.The fse adjusted the bent fixing of the cart.The fse performed a routine inspection as inspection was due.During the inspection, an electrical test fails #50 was observed.The fse replaced the main board and motor control board.It was also confirmed that blood had entered the internal filter.The fse replaced the crm, purge valve, and blood detect tubing.An inspection was then performed to confirm that there were no issues with the unit's operation.
Event or Problem Description
It was reported that when the machine was brought into the company and during a regular inspection performed by a getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) could not be fixed to the transport cart, the electrical test fails code #50 had occurred, and blood had intruded into the iabp.There was no patient involvement.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• 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: 17671317
• Report Number: 2249723-2023-03891
• Device Sequence Number: 20385339
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: 10607567108803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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-UC-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 09/01/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown