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 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during preventive maintenance (pm) performed by a getinge service territory manager (stm) , the cardiosave intra-aortic balloon pump (iabp) unit failed pim test/ pressure testing.There was no patient involvement.

Manufacturer Narrative

Updated fields: b4,d9,g3,g6,h2,h3,h4,h6(type of investigation, investigation findings, component codes,investigation conclusions), h10.Additional info: (b)(6).It was reported that the cardiosave intra-aortic balloon pump (iabp) failed pim test/pressure testing.There was no patient involvement and no harm reported.A getinge field service engineer (fse) replaced (d997-00-1178) pneumatic module assy due to failed leak testing and (d012-00-1808) cable,fiber optic jumper replaced due to testing at the extreme limits.The unit passed all functional and safety tests to factory specifications.Unit was cleared for clinical use.The defective components were received for further investigation.The failure analysis and testing dept.Received parts with a reported unit failure of a pim leak during testing and the fiber optic cable being tested at limit.The fat performed a visual inspection and found the part to be in good condition.Ran the all manifold test and the pim part failed the pressure differential test.This verifies the reported failure of pim.This part passed the fiber optic test within optimal standards.Could not verify any issue.Retaining the parts in the failure analysis and testing department per procedure number 0002-07-d008 rev.Ap.The non-conformances with the returned pim part were confirmed.However, the root cause or the most probable root cause is impossible to be defined.The non-conformances with the returned fiber optic jumper were not confirmed.Therefore, the 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: 17463520
• MDR Text Key: 320708619
• Report Number: 2249723-2023-03541
• 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: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• 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?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: N/A.