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

Model Number 0998-00-0800-45

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Moisture or Humidity Problem (2986)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit displayed power up test failed.The perfusionist called about a patient on a cardiosave, and a cardiosave that was removed from the patient for "power up test fails".He states that earlier in the day, the first cardiosave was having issues with lots of condensation in the helium tubing.They emptied the tubing several times and at one point rebooted the pump.On start up they noticed the "power up test fail code numbers 4 and 5." they replaced that pump for another cardiosave.He stated states that they were low on pumps, and that the he knew that the second cardiosave had already had issues with "power up test fails" but placed it on the patient anyway.They continued to have an issue with condensation for awhile after, but currently it is working well now.There are no current alarms on the second pump, but it will be reported due to the earlier "test fails".He states that he took the first pump back to his office and it "failed" in 4 attempts on start up.At the fifth attempt he states that it powered up without an alarm or issue.Both pumps will be sent to their biomed department.There were no harm or injury to the patient.This report is for the first iabp that was removed from the patient.The replacement pump is from complaint # (b)(4) and is being reported separately.

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) unit displayed power up test failed.The perfusionist called about a patient on a cardiosave, and a cardiosave that was removed from the patient for "power up test fails".He states that earlier in the day, the first cardiosave was having issues with lots of condensation in the helium tubing.They emptied the tubing several times and at one point rebooted the pump.On start up they noticed the "power up test fail code numbers 4 and 5." they replaced that pump for another cardiosave.He stated states that they were low on pumps, and that the he knew that the second cardiosave had already had issues with "power up test fails" but placed it on the patient anyway.They continued to have an issue with condensation for awhile after, but currently it is working well now.There are no current alarms on the second pump, but it will be reported due to the earlier "test fails".He states that he took the first pump back to his office and it "failed" in 4 attempts on start up.At the fifth attempt he states that it powered up without an alarm or issue.Both pumps will be sent to their biomed department.There were no harm or injury to the patient.This report is for the first iabp that was removed from the patient.The replacement pump is being reported separately.Reference manufacturing report number from (b)(4).

Manufacturer Narrative

Corrected data: b5 updated data: b4, g3, g6, h2, h10, h11.

Manufacturer Narrative

A getinge field service engineer (fse) stated that perfusionist calling about a patient on a cardiosave, and a cardiosave that was removed from the patient for "power up test fails".He states that earlier in the day, the first cardiosave was having issues with lots of condensation in the helium tubing.They emptied the tubing several times and at one point rebooted the pump.On start up they noticed the "power up test fail code numbers 4 and 5." they replaced that pump for another cardiosave.Todd states that they were low on pumps, and that the he knew that the second cardiosave had already had issues with "power up test fails" but placed it on the patient anyway.They continued to have an issue with condensation for awhile after, but currently it is working well now.There are no current alarms on the second pump, but it will be reported due to the earlier "test fails".Todd states that he took the first pump back to his office and it "failed" in 4 attempts on start up.At the fifth attempt he states that it powered up without an alarm or issue.Both pumps will be sent to their biomed department.Todd says that dottie from getinge service is scheduled to service the pumps on friday.A getinge field service engineer (fse) evaluated the unit and confirmed the drive manifold fail test.Fse replaced the drive manifold.

Event Description

N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: 17781594
• MDR Text Key: 323843034
• Report Number: 2249723-2023-04113
• Device Sequence Number: 1
• Product Code: DSP
• 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,Followup
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 80 KG