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 Restricted Flow rate (1248); Environmental Compatibility Problem (2929); Appropriate Term/Code Not Available (3191)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp)displayed system failure alarm.Icu nurse called getinge clinical support regarding the issue.The nurse was unable to resolve using iab fill key.Tubing was clear, connections tight.Nurse reported a lot of condensation in helium tubing.Icu staff getting patient back to bed and going to reposition patient and catheter.Getinge clinical support recommended nurse disconnect helium tubing from pump, and then shake and/or suction out the fluid.Getinge clinical followed up with nurse and learned unit surfaced restriction alarms and unable to restart pump.Nurse then surfaced a loud noise (cardiosave critical alarm) with cardiosave displaying system failure.There was no patient harm or injury reported.

Event Description

N/a.

Manufacturer Narrative

Additional contact details: (b)(6).A getinge field service engineer (fse) stated that he unable to replicate user complaint.Successfully completed functional check on unit upon initially testing with testing catheter and trainer.Identified however moisture traces on testing catheter.Inspected unit internally.Identified moisture inside the safety disk, pim, pim to fll manifold lines, going to the pressure/vacuum reservoir.Completed various condensation removal procedures (crp) before proceeding with testing.Post crps, identified moisture spraying out of pim catheter insertion port.Identified code 124 in the logs on 26 october around 1500 hours, drive transducer out of calibration, correlating with system failure prompt.Logs attached for reference.Identified moisture on safety disk side going into drive manifold right in line with drive transducer.Replaced drive and vacuum transducers as a precaution.Calibrated transducers.Post replacement and calibration, successfully completed a full function check without issue.Unit calibrated and passed all functional and safety tests per factory specifications.Service completed.

• 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: 18067553
• MDR Text Key: 327314810
• Report Number: 2249723-2023-04737
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 57 KG