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

Model Number 0998-00-0800-52

Device Problem Leak/Splash (1354)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device(10) a getinge field service engineer (fse) was dispatched to evaluate this unit.Fse found the helium cylinder to not be seated correctly, hence slightly leaking.Fse removed cylinder, replacement gas seal was fitted, and cylinder was re-seated correctly.Next, fse fixed cylinder into position via tbar handle screw.Fse then opened cylinder valve and saw no leaks present and system pressure gauge reading was midway in the 'green zone'.Fse advised customer that cylinder was about half full/empty.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had helium leaking.There was no patient involvement, thus there was no adverse event reported.

Manufacturer Narrative

Updated fields; b4, g2, g3, g6, g7, h2, h4, h6 (type of investigation, investigation findings, investigation conclusions), h10, h11.Corrected fields: g1, h6 (component codes).

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Updated fields: b4, g3, g6, h2, h10, h11.Corrected fields: h6(component codes).The repair was carried out on-site, and subsequently cleared for clinical use.

• Brand Name: CARDIOSAVE HYBRID, TYPE G 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: 12698980
• MDR Text Key: 278404878
• Report Number: 2249723-2021-02461
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: 10607567108438
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/28/2022

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: Other
• Device Model Number: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 11/22/2022; 11/22/2022
• Supplement Dates FDA Received: 11/23/2022; 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose