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 Inability to Auto-Fill (1044); Unexpected Shutdown (4019)

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

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was able to duplicated the reported issue using a test catheter and trainer.The fse inspected the pneumatic module assembly (pim) and found saline residue inside pim channels and on safety disk.The fse replaced the pim.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.A supplemental report will be submitted upon completion of our investigation.

Event Description

It was reported that during use the cardiosave intra-aortic balloon pump (iabp) had fault 58 system shutdown error.The iabp unit was swapped out with another iabp unit to continue therapy without issue.There was no patient harm, and no adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g3, g6, g7, h2, h4, h6(investigation type, investigation findings & investigation conclusions), h10, h11.Corrected fields: a1, b5, b6, b7, d9, g1(contact person), h6(component codes & impact codes).

Event Description

It was reported that before use the cardiosave intra-aortic balloon pump (iabp) had fault 58 system shutdown error.There was no patient involvement, and no adverse event was 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: 12571645
• MDR Text Key: 274599311
• Report Number: 2249723-2021-02245
• 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
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1