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 Problem Gas/Air Leak (2946)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) customer called and described an alarm that started directly after switching iab frequency from1:1 to 1:2.States the alarm appeared around every hour, the alarm was a gas gain alarm.Stated that there were no visible signs of blood in the helium tubing, no kinks in the catheter and all connections are secured.The console was switched over to continue therapy and there was no patient harm reported.

Event Description

N/a.

Manufacturer Narrative

Updated fields:h6 (type of investigation, investigation findings, investigation conclusions).It was being reported that the cardiosave intra aortic balloon pump (iabp) had an issue regarding the "pump".(b)(6) rn of the hospital describing a situation where the alarm had started to occur directly after switching the iab frequency from 1:1 to 1:2.She also states that the alarm has been appearing around every hour.She does know the exact wording of the alarm and than fse had directed her to print a trigger and alarm log to review the alarms.At the time she begins reading the alarms to fse since their call has been disconnected.Than fse attempted multiple times to call her back and even went through the main operator but couldn't get an answer at the ccu desk.At 4:47 pm she calls fse back and stated that she apologized that they are having the phone issues.She details a gas gain alarm that has been occurring.She describes that they are frustrated by the number of times the alarm has occurred during her shift.Than fse had reviewed the troubleshooting with her.(b)(6) had also reported that there is no visible signs of blood in the helium tubing , no visible kinks in the catheter , and all connections are secured.Use of the "iab fill" and "start" keys are reported to be used on each occurrence.After that the options are being reviewed with (b)(6) and she and the charge nurse had decided to change the therapy to a different cardiosave unit.Fse also guided them through switching over the therapy with minimal down time of less than a minute.Even after several times during the call fse had tried to identify the iab catheter which is being involved.But it seems difficult in order to obtain the catheter information.(b)(6) had also asked for the cardiosave to be tested/serviced before being putting back into it's use.At the change of shift at 8:09 pm fse had called again to check on the given issue.(b)(6) had also stated that she is giving report to (b)(6) at this time and (b)(6) will continue the care for the patient.(b)(6) had also stated that she will call fse back to give catheter information.At 9:37 pm fse had called again to obtain the information.(b)(6) had also reported that they have not had the alarm occur again since the physician ordered frequency to return to 1:1.(b)(6) is finally able to verify the iab catheter is an arrow 7.5fr 30cc with the marking "ok3107" on the "y" fitting.Fse had thanked her for the information , and she had thanked fse for calling again to check on the progress of the therapy.(b)(6) has been notified via email.Despite gfes (good faith efforts), no response received regarding any repair or the status of the iabp.If any pertinent information is received in the future , the complaint will be reopened and updated accordingly.H3 other text : customer not responded.

• 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: 18439737
• MDR Text Key: 331859916
• Report Number: 2249723-2024-00030
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• 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: 05/28/2024

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: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/25/2023
• Initial Date FDA Received: 01/03/2024
• Supplement Dates Manufacturer Received: 01/18/2024; 05/28/2024
• Supplement Dates FDA Received: 01/22/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ARROW 30CC 7.5FR OK31017.