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

Model Number N/A

Device Problem Gas Output Problem (1266)

Patient Problem Death (1802)

Event Date 07/31/2020

Event Type  Death  

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) evaluated the iabp and confirmed a sole incident of gas gain error in the diagnostic fault logs but could not replicate the error.The stm performed functional testing and safety checks to factory specifications which all passed, and the iabp unit was returned to the customer and cleared for patient use.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a gas gain error.The iabp was swapped for another and functioned properly with no alerts.No patient harm, serious injury or adverse event was reported.It was reported that the intra-aortic balloon catheter (iabc) was removed after a few hours for comfort care and the patient subsequently expired.Additionally, the customer advised that the patient expired because of sickness, and that they were not filing complaint on our hardware or balloon.A separate report will be submitted for the iabc involved.

Manufacturer Narrative

Updated fields: h6 (evaluation method code).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) had a gas gain error.The iabp was swapped for another and functioned properly with no alerts.No patient harm, serious injury or adverse event was reported.It was reported that the intra-aortic balloon catheter (iabc) was removed after a few hours for comfort care and the patient subsequently expired.Additionally, the customer advised that the patient expired because of sickness, and that they were not filing complaint on our hardware or balloon.A separate report will be submitted for the iabc involved.

• 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: 10447277
• MDR Text Key: 204159383
• Report Number: 2249723-2020-01338
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SENSATION PLUS 50ML; SENSATION PLUS 50ML.
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Weight: 76