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 Problem Pressure Problem (3012)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventative maintenance by getinge field service engineer, the cardiosave intra-aortic balloon pump (iabp) unit compressor pressure was failing to raise pressure above 385 mmhg as part of the drive regulator calibration.Also, compressor would take about 30 - 40 seconds to get to 385 mmhg as part of the pressure regulator test.The fiber optic test waveform barely above a flat line during testing.Compressor output test reading at approximately 900 rpm, producing a muffled sound.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4, d9 (device available for eval, return to manufacture date), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, component codes and investigation conclusions), h10, h11.Corrected fields: e1(initial reporter, event site email), e2, e3, g2.A getinge field service engineer evaluated the unit and when initially tested, unit would commence inflating, systematically deflating the balloon waveform to a fat line, going back up, to then fat out, continuing the loop while pumping.Unit all up to specifications, otherwise.Pressure regulator calibration would fail to raise pressure to 390 mmhg, taking about a full minute to get to 390 mmhg +-10 mmhg.Vacuum regulator calibration without issue.Compressor output test failed to raise pressure above 1100 rpm, making a drowning sound.Narrowed down issue to compressor.Replaced compressor and successfully addressed the issue.Completed full function check post compressor replacement without issue.Nothing unusual identifed in the logs, attached for reference.Unit calibrated and passed all functional and safety tests per factory specifcations.Returned to customer and cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing dept.Received part number with a reported unit failure of a defective compressor.The fat performed a visual inspection and found the part to be in good condition.The fat installed the compressor in cardiosave test fixture and tested the part to factory specifications per the cardiosave service manual part number 0070-00-0639 revision r.Calibrated and tested the regulator pressures with no issues found there.Pumped the cardiosave for 3 hours with no issues found.Fat was not able to replicate any problem.No root cause confirmed.Retaining the part in the failure analysis and testing department per procedure number (b)(4).The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.

Event Description

N/a.

• 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: 17689033
• MDR Text Key: 322705975
• Report Number: 2249723-2023-03914
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.