MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-62
Medical Device Problem Codes	Pumping Stopped (1503); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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 use on a patient, the cs100 intra-aortic balloon pump (iabp) has an infiltration of blood into the internal circuits of the device with a sudden stop of the machine.
Event or Problem Description
It was reported that, the cs100 intra-aortic balloon pump (iabp) has an infiltration of blood into the internal circuits of the device with a sudden stop of the machine.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, component code, investigation conclusion), h10, h11 corrected fields: d5, e2, g2 additional information: e3 is unknown (initially it is submitted as "other healthcare professional").It was reported that the cs100 intra-aortic balloon pump (iabp) had an infiltration of blood into the internal circuits of the device with a sudden stop of the machine.There was no patient involvement.Despite gfes (good faith efforts), no response has been received regarding any repair or the status of the iabp.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid.A valid serial number of the device has not been provided therefore the production identifier component of the udi is not available information regarding the serial number of the device has not been provided from the customer despite multiple attempts to obtain the information, therefore, the production identifier component of the udi is not available.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18154543
• Report Number: 2249723-2023-04920
• Device Sequence Number: 17781954
• Product Code: DSP
• UDI-Device Identifier: 10607567112664
• UDI-Public: (01)10607567112664(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/20/2024

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: Other
• Device Model Number: 0998-00-3013-62
• Device Catalogue Number: 0998-00-3013-62
• 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: 11/03/2023
• Supplement Date Received by Manufacturer: 12/12/2023; 05/14/2024; 10/09/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/14/2023; 05/14/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; UNKNOWN.
• Patient Sex: Unknown