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

Model Number N/A

Device Problem Inability to Auto-Fill (1044)

Patient Problem Chest Pain (1776)

Event Date 08/26/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge service territory manager (stm) was dispatched to evaluate the iabp.The fse evaluated the logs and confirmed autofill failures.Upon first testing the unit, the stm was able to run simulated treatment without issue and was unable to replicate customer's complaint.However, the stm observed the fiber optic connector physically broken, the power activity log showed normal activity, dead volume errors related to autofill which were more likely related to the disconnection - nothing else unusual was identified in the logs.Unrelated to the complaint issue, the stm replaced the 9v battery as it was unresponsive and replaced the safety disk as it was coming up due for expiration at 6,000,000 cycle interval.In addition, the fiber optic connector sliding cover was also broken and the stm replaced the broken front panel and related labels along with the broken fiber optic connector and the tether assembly which was not retracting.The unit was then calibrated and passed all functional and safety tests per factory specifications after which it was returned to customer and cleared for clinical use.The full name of the initial reporter was not provided.

Event Description

It was initially reported, that the cardisoave intra-aortic balloon pump (iabp) shutdown during use on a patient.It was later clarified that the iabp unit displayed numerous autofill failures during the event and never shut down during use on the patient.The unit was reportedly turned off by the registered nurse/csicu (cardiac surgical intensive care unit).Additionally, it was reported that the patient experienced chest pain with no adverse reactions.The clinicians opted to take out the intra- aortic balloon catheter (iabc) and discontinued the therapy at that time.Please refer to related mfg report #2248146-2019-00749 on the involved iabc.

Event Description

It was initially reported, that the cardiosave intra-aortic balloon pump (iabp) shutdown during use on a patient.It was later clarified that the iabp unit displayed numerous autofill failures during the event and never shut down during use on the patient.The unit was reportedly turned off by the registered nurse/csicu (cardiac surgical intensive care unit).Additionally, it was reported that the patient experienced chest pain with no adverse reactions.The clinicians opted to swap out the unit for another and take out the intra- aortic balloon catheter (iabc) and discontinued the therapy at that time.Please refer to related mfg report #2248146-2019-00749 on the involved iabc.

Manufacturer Narrative

Corrected fields: b5, g4 (initial emdr should have read aug-28-2019).

• 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 07430
• MDR Report Key: 9100859
• MDR Text Key: 159517111
• Report Number: 2249723-2019-01521
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON CATHETER.; BALLOON CATHETER.; BALLOON CATHETER
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Weight: 91