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

Model Number	0998-00-3013-68
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the during an inspection on the cs100 intra-aortic balloon pump (iabp) blood was identified on the safety disk.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
A getinge field service engineer (fse) states, it was necessary to open the equipment to carry out an internal inspection where it was found that blood unfiltered the drive manifold, safety disk and other parts which were contaminated by blood.It was also verified in service mode that the battery had expired and (pm) was overdue.The fse also stated that the blood infiltrated due to the operator not interrupting use after the equipment alarmed.The equipment is out of use and is waiting for the requested parts to be replaced.At this time, the customer has not approved the purchase of new parts from getinge.A supplemental report will be submitted if additional information is received.
Event or Problem Description
It was reported that the during an inspection on the cs100 intra-aortic balloon pump (iabp) blood was identified on the safety disk.There was no harm or injury.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V
• 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: 18301688
• Report Number: 2249723-2023-05217
• Device Sequence Number: 7152558
• Product Code: DSP
• UDI-Device Identifier: 10607567107691
• UDI-Public: (01)10607567107691(21)SA283001G8
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2024

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: 0998-00-3013-68
• Device Catalogue Number: 0998-00-3013-68
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 03/12/2024; 09/25/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/13/2024; 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown