MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-32
Medical Device Problem Codes	Inability to Auto-Fill (1044); Inflation Problem (1310); Battery Problem (2885)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a cardiac surgical procedure, the cardiosave hybrid intra aortic balloon pump (iabp) displayed an ¿automatic fill failure¿ error.According to the hospital¿s clinical engineering manager, the patient did not respond following return from extracorporeal surgery.The clinical team attempted to use the cardiosave device for reversal; however, the device displayed an automatic inflation failure error and could not be used.No adverse event was internally recorded by the institution at the time of the occurrence.The patient died.Nursing staff did not confirm that the patient¿s death was a consequence of the device error.
Additional Manufacturer Narrative
E.Initial reporter: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported that during a cardiac surgical procedure, the cardiosave hybrid intra aortic balloon pump (iabp) displayed an autofill failure error.The patient did not respond following return from extracorporeal surgery.The patient died.Nursing staff did not confirm that the patient¿s death was a consequence of the device error.
Additional Manufacturer Narrative
Updated fields - b4, d9, e2, e3, g3, g6, g7, h2, h3, h6(medical device ¿ problem code, type of investigation, investigation findings, component codes), h11 corrected fields - b5, d1, d4(version or model, catalog, udi), d8, d10, g2.A third-party engineer evaluated the unit for the reported malfunction.A simulator test was repeated, but a balloon with a leak was used.The device exhibited the same error reported by the customer.The pneumatic module leak test, all manifold test, compressor output test, and compressor cycle test all passed.The battery maintenance test failed on both batteries.It is unclear if the batteries were expired.The engineer concluded that the reported failure was a result from using the device with a leaking intra-aortic balloon.The engineer completed preventive maintenance (pm).The batteries, pressure reserve filter, vacuum inlet filter, buna-n 1-008 n70 o-ring, and safety disk were all replaced.

• Brand Name: CARDIOSAVE HYBRID TYPE J PLUG
• 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 24884887
• Report Number: 2249723-2026-0002321
• Device Sequence Number: 9897102
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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
• Device Model Number: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 04/15/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2020
• 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: IAB; INTRA-AORTIC BALLOON CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown