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

Model Number	0998-00-0446-61
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Type of investigation not yet determined : the customer has been presented with a quote for the cost estimate for repairs.Additional information is being requested with regards to the patient complication.Additionally, a report of user error was provided and we are seeking additional clarification.A supplemental report will be submitted upon completion of our investigation or if additional information is provided.
Event or Problem Description
It was reported by the customer that the cs300 intra-aortic balloon pump (iabp) unit had blood backed all the way through the tubing and potentially into the machine.It was reported that the patient had a complication that was not due to the cs300 device.
Additional Manufacturer Narrative
Corrected fields: h6 (type of investigation, component codes).Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate.The fse observed traced of blood in the purge line up to the tank tubing after the purge valve assembly.The fse replaced all blood contaminated parts which include the pneumatic component male luer, reservoir assembly, fill manifold bracket, purge valve assembly, fill manifold assembly, block single transducer, blood detect tubing, condensation removal module, and safety disk.During testing, the fse observed that the drive manifold was leaking.This unrelated issue will be documented on a separate medwatch report.The iabp unit remains out of use pending additional repairs.A supplemental report will be submitted when additional information is provided.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) had blood backed all the way through the tubing and potentially into the machine.There was no patient harm and no adverse event was reported.
Additional Manufacturer Narrative
Additional information: (event site postal code: (b)(4)).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 110V
• 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: 13536784
• Report Number: 2249723-2022-00302
• Device Sequence Number: 5075529
• Product Code: DSP
• UDI-Device Identifier: 10607567108292
• UDI-Public: 10607567108292
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-0446-61
• Device Catalogue Number: 0998-00-0446-61
• 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: 01/20/2022
• Supplement Date Received by Manufacturer: 04/04/2022; 04/19/2022; 06/05/2022; 02/28/2024
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 04/29/2022; 05/12/2022; 12/14/2022; 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/1998
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRA-AORTIC BALLOON CATHETER
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown