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

Model Number	0998-00-0800-35
Medical Device Problem Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer on monday evening ((b)(6) 2023) the representative of gauteng was contacted regarding an autofill failure error on the cardiosave intra-aortic balloon pump (iabp).When they initialized the therapy the autofill failure error alarmed.They followed the help screen instructions on the pump and as last resort they swapped out the balloons to establish if it was the consumable, but even with replacing of the balloon they got the same error.At this time the representative was contacted, and she did some more troubleshooting over videocall with them.Helium was checked, tubing used, iab fill was done and even manual fill of the balloon, but the error persisted.Ap waveform as well as ecg was traced on the pump.The therapy was stopped due to the fact that the customer does not have a backup pump, cardiosave was bought without a backup unit.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer on monday evening (24 july 2023) the representative of gauteng was contacted regarding an autofill failure error on the cardiosave intra-aortic balloon pump (iabp).When they initialized the therapy the autofill failure error alarmed.They followed the help screen instructions on the pump and as last resort they swapped out the balloons to establish if it was the consumable, but even with replacing of the balloon they got the same error.At this time the representative was contacted, and she did some more troubleshooting over videocall with them.Helium was checked, tubing used, iab fill was done and even manual fill of the balloon, but the error persisted.Ap waveform as well as ecg was traced on the pump.The therapy was stopped due to the fact that the customer does not have a backup pump, cardiosave was bought without a backup unit.There was no patient harm reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: (device available for eval, return to manufacture date), (type of investigation, investigation findings, component codes and investigation conclusions).A getinge field service engineer (fse) evaluated the unit and resolved the issue by replacing assy,helium reservoir.Fse then tested safety and functionality of the device and iabp was released for clinical use.The defective components were received for further investigation.The failure analysis and testing dept.Received helium reservoir, with a reported unit failure of an autofill failure.The fat performed a visual inspection and found the part to be in good condition.The fat installed the helium reservoir in cardiosave test fixture and tested the part to factory specifications.Part failed the all manifold test, indicating there was a leak.Fat confirmed the reported failure of the part.Retaining the part in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.

• Brand Name: CARDIOSAVE HYBRID TYPE M PLUG
• 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: 17497171
• Report Number: 2249723-2023-03608
• Device Sequence Number: 2442335
• Product Code: DSP
• UDI-Device Identifier: 10607567109107
• UDI-Public: 10607567109107
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024

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: 0998-00-0800-35
• Device Catalogue Number: 0998-00-0800-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/11/2023; 04/24/2024
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 08/16/2023; 04/24/2024
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 89 KG