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

Model Number N/A

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and opened up the "help" screen and followed the prompts which directed to restart the iabp unit by depressing the "green" button on the back on the iabp unit for 2 seconds, then wait 10 seconds before turning on the iabp unit.When the iabp unit was turned on the iab was observed to function normally.The fse also noted that the iabp unit did not feel hot and there was nothing in front of the vent.The fse advised the customer's trained biomed to check the compressor output test and temperature.The biomed reported that both tests functioned normally and was unable to duplicate the reported issue after running the iabp unit for the whole day.The fse advised that the compressor and temperature sensor be replaced to avoid re-occurrence.The fse has verified that the customer has replaced the necessary parts (not provided) and tested the iabp unit.Currently, the iabp unit is functioning normally and the customer is completing functional testing and preventative maintenance on the iabp unit.A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump generated a "constant tone alarm" and the intra-aortic balloon (iab) stopped inflating.A message appeared of the screen stating that the iabp unit had overheated.It was later reported that the end user was able to restart the iabp unit to continue therapy without issue.It was later reported that patient therapy was completed successfully.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

A getinge field service engineer (fse) reported that the parts replaced were the compressor and the temperature sensor.The iabp was tested and a preventive maintenance (pm) was performed.All tests passed.The unit has been placed back in clinical service.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump generated a "constant tone alarm" and the intra-aortic balloon (iab) stopped inflating.A message appeared of the screen stating that the iabp unit had overheated.It was later reported that the end user was able to restart the iabp unit to continue therapy without issue.It was later reported that patient therapy was completed successfully.There was no patient harm and no adverse event was reported.

Manufacturer Narrative

The suspected faulty scroll compressor was returned to getinge's national repair center (nrc) for failure analysis.A technician of the nrc inspected the scroll compressor per the cardiosave service manual and to the ipc-a-610 standard, with no visual damage observed.The technician then installed the compressor into a cardiosave test fixture and tested the compressor to factory specifications per the cardiosave service manual.The compressor failed with an over temperature alarm after running for approximately four hours.The nrc verified the failure of over temperature alarm.The compressor failed testing and has been sent to getinge's research and development for failure analysis per procedure.Updated fields: b4, g4, g7, h2, h10, h11.Corrected fields: h6 (evaluation result and conclusion codes).

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump generated a "constant tone alarm" and the intra-aortic balloon (iab) stopped inflating.A message appeared of the screen stating that the iabp unit had overheated.It was later reported that the end user was able to restart the iabp unit to continue therapy without issue.It was later reported that patient therapy was completed successfully.There was no patient harm 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 07430
• MDR Report Key: 9521413
• MDR Text Key: 191404582
• Report Number: 2249723-2019-02086
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• 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: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MAQUET BALLOON - UNKNOWN TYPE; MAQUET BALLOON - UNKNOWN TYPE; MAQUET BALLOON - UNKNOWN TYPE