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); Communication or Transmission Problem (2896)

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

Event Date 08/04/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: a getinge field service engineer (fse) evaluated the unit and confirmed the reported issue.The fse observed fault 124 and 37 logged in system.Upon performing the test "all manifold test (leak)" it was found that the valves k4 and k10 have a small leak.To resolve the issue, the fse replaced pim assembly and the transducers were re-calibrated.Device now passes all functional tests.Device was allowed to pump using patient simulator for 2 hours after technician departure with no additional failures.The fse performed all manifold tests once again, and the unit passed all tests.No further leaks were observed.Autofill tests were performed multiple times (successfully) using the trainer and the customer's patient simulator.Device is capable of performing a successful autofill upon each attempt.Device cleared for clinical use and returned to the customer.The full name of the initial reporter is (b)(6).The full name of the event site was shortened due to field character limit; the full name is (b)(6).

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had autofill failure and an internal communication failure.It is unknown the circumstances under which the event occurred.It is also unknown if there was a patient involvement.However, there was no adverse event reported.

Event Description

It was reported that during setup, the cardiosave intra-aortic balloon pump (iabp) had autofill failure and an internal communication failure.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

Updated fields: h6 (health effect-impact codes).

• 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: brian schaeffer ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 12414698
• MDR Text Key: 269560909
• Report Number: 2249723-2021-01988
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose