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 No Audible Alarm (1019); Pumping Stopped (1503)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/07/2022

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stops pumping - does not alarm.

Manufacturer Narrative

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

Manufacturer Narrative

Updated data: b4,e1(email),g3,g6,h2,h10,h11.Corrected data: b3,b5,e3,h6(clinical&impact).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) stops pumping - does not alarm.There was no patient harm reported.

Manufacturer Narrative

Updated fields: b4, d9, e1 (site country), g3, g6, h2, h3, h4, h6 (type of investigation, investigation findings and investigation conclusions), h10.A getinge field service engineer (fse) was dispatched to evaluate the iabp unit and unable to reproduce issue, logs show no technical alarms or failures.The fse replaced front end board as precaution.Unit passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.Patient involvement was there, no adverse event was reported.The failure analysis and testing dept.(fat) recieved the front end board was observed per the cardiosave service manual part number 0070-00-0639 revision q with no visual damage.The failure analysis and testing dept.Installed the front end board into the cardiosave test fixture and tested the front end board to factory specifications per procedure number 0002-07-d016 revision d and the cardiosave service manual part number 0070-00-0639 revision q.Tested front end bd.And was unable to duplicate the failure of unit stops pumping after hours of run time.Fat dept.Tested board for over 3 hours.The front end board will be held to the fat dept.Per procedure number 0002-07-d008 revision al.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is "not confirmed".

• 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: 15881064
• MDR Text Key: 305053144
• Report Number: 2249723-2022-03041
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2022
• 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: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.