MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID W/ E/F PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-55

Device Problem Gas/Air Leak (2946)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: the getinge fse replaced the helium regulator to correct the issue.Subsequently, the fse completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.It is expected that the suspected faulty helium regulator will be returned to getinge's national repair center (nrc) for failure analysis; a supplemental report will be submitted when additional information is provided.The initial reporter named is a getinge employee whose contact details differ from that of the event site.A contact at the event site is: (b)(6).

Event Description

It was reported that during a demonstration to the customer performed by a getinge field service engineer (fse) and post installation, the cardiosave intra-aortic balloon pump (iabp) was observed to have a leak on the helium regulator.There was no patient involvement and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, d9, g3, g6, h2, h4, h10 a getinge field service engineer (fse) evaluated the unit and confirmed the helium leak.The getinge fse replaced the helium regulator, safety disk and tidal volume disk to correct the issue.The fse performed the function check and calibration.The helium leak test was performed and passed to manufacture specifications.The defective parts replaced were scrapped.The iabp unit was cleared for clinical use and released to the customer.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 12585567
• MDR Text Key: 275041563
• Report Number: 2249723-2021-02272
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: 10607567108414
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1