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 No Display/Image (1183)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device (10/213): the getinge field service engineer (fse) arrived onsite to evaluate the complaint and initially could not replicate the reported issue upon using the testing catheter and the trainer, there was also nothing unusual found in the logs.The fse did identify that the coiled cord was turning 45 degrees to disconnection when manipulated, he also identified traces of saline on top of the console into the coiled cord to the back plane board cord.There was also traces of saline behind the front end module, with small traces going into the battery bay 1 without any damage showing.He continued to evaluate and observed traces of an unknown brown sticky substance inside the console, behind the printer without traces on the backplane board.To fix the issue the fse, replaced the coiled cord, coiled cord to the backplane board, and the backplane board as a precaution.He also replaced the damaged front end module, and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released to the customer and cleared for clinical service.A supplemental report will be submitted upon completion of our investigation.The full event site name is university of (b)(6) center.

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) screen froze, the customer swapped the unit and continued treatment without an issue.No patient harm, serious injury or adverse event was reported.

Event Description

N/a.

Manufacturer Narrative

Corrected fields: d11, g1(contact person), h6(component codes).The following investigation was performed at getinge's national repair center (nrc).Inspection of the pcb,backplane, rohs was completed per the cardiosave service manual and to the ipc-a-610 standard with a white residue being observed around component l1, which is consistent with saline.The board cannot be tested due to the saline spill.Inspection of the pcb,front end, rohs was completed per procedure and to the (b)(4) standard with a white residue being observed around component c169, which is consistent with saline.The board cannot be tested due to the saline spill.Inspection of the coiled cord to backplane board cord was completed per the cardiosave manual and to the (b)(4) standard with a white residue observed to the connector and grommet of the cable, which is consistent with saline.Inspection of the coiled cord part number 0012-00-1801 was completed per the cardiosave service manual and to the (b)(4) standard with a white residue being observed on the connector release of the cable, which is consistent with saline.The four parts will be retained in the nrc per procedure.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that before connection to a patient the cardiosave intra-aortic balloon pump (iabp) screen froze, the customer swapped the unit and commenced treatment without an issue.There was no patient involvement, and no adverse event reported.

• 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: 12673759
• MDR Text Key: 278125200
• Report Number: 2249723-2021-02408
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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,Followup
• Report Date: 08/02/2022

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: Health Professional
• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/21/2021
• Supplement Dates Manufacturer Received: 03/29/2022; 04/30/2022; 08/02/2022
• Supplement Dates FDA Received: 04/25/2022; 05/26/2022; 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER