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

Model Number 0998-00-0800-53

Device Problems Failure to Zero (1683); Inappropriate Waveform (2536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit was unable to obtain an aline waveform pressure.The unit was swapped out to continue therapy.There was no patient harm reported.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

It was reported that cardiosave intra aortic balloon pump(iabp) that was placed on a patient on aug 23 in the cath lab.She says that the balloon is fiberoptic and they were unable to obtain an aline waveform or pressure.The cardiosave would pump, but there was no aline.They quickly switched pumps to a cs300, connected the same fiberoptic cable and it worked.There was an aline, the pump zeroed and there were bp numbers.She wanted to report the pump, and ask for service.She states the biomed engineers are aware of the issue, and have contacted the local getinge service technician, but unsure of when they are able to come.Advised by a getinge field service engineer (fse) would create a complaint, and ask tech support if there is a service order in place already.Information was taken for the complaint, and she had no further questions.No report of adverse outcome regarding the patient.No further information available by performing gfe.Repair service not done.

• Brand Name: CARDIOSAVE HYBRID, TYPE B PLUG
• Type of Device: 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: 15339831
• MDR Text Key: 302953401
• Report Number: 2249723-2022-02242
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

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
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/01/2022
• Supplement Dates Manufacturer Received: 04/06/2024
• Supplement Dates FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2021
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: A MAQUET SENSATION 40CC IAB WAS USED
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 116 KG