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

Model Number N/A

Device Problems Communication or Transmission Problem (2896); Audible Prompt/Feedback Problem (4020)

Patient Problem No Patient Involvement (2645)

Event Date 05/06/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit is not required to be reviewed per getinge standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to evaluate the iabp unit and powered the iabp on and observed that the iabp completed all power on self-tests successfully.The stm allowed the iabp to remain in standby for approximately 30 minutes without any alarms or errors occurring.The stm connected a known system trainer, known balloon, and initiated pumping and allowed iabp to run for approximately 30 minutes without any errors or alarms occurring.The stm troubleshot the iabp and discovered fault code '67' had occurred 376 times indicating a potential failure with the front end board.The stm additionally discovered fault code '107' had occurred 190 times indicating a potential failure with the power management board.To address the issue the stm replaced the front end board and the power management board, and performed a full preventive maintenance (pm); safety, calibration, and functionality checks passed to factory specifications.The stm then powered the iabp on and allowed the iabp to remain in standby for approximately 30 minutes without any alarms or errors occurring.The stm then connected a known system trainer and known balloon and allowed the iabp to run for approximately 60 minutes without any errors occurring.The iabp unit was functioning in accordance with factory specifications.The iabp was then returned to the customer and cleared for clinical service.The power management board was requested to be returned for failure investigation.Once this investigation is completed, a supplemental report will be submitted.(b)(6).

Event Description

It was reported that before use on a patient, the cardiosave intra-aortic balloon pump (iabp) was powered on and the iabp unit successfully completed all power on self tests.The iabp was then brought into the cath lab and left in "stand by" mode for approximately 5 minutes while patient was prepped.After approximately 5 minutes end user reported that the iabp emitted a "loud, squealing audible alarm" and the display of the iabp indicated an "internal error" had occurred, the iabp was then swapped.There was no patient involvement, and no adverse event reported.

Event Description

It was reported that before use on a patient, the cardiosave intra-aortic balloon pump (iabp) was powered on and the iabp unit successfully completed all power on self tests.The iabp was then brought into the cath lab and left in "stand by" mode for approximately 5 minutes while patient was prepped.After approximately 5 minutes end user reported that the iabp emitted a "loud, squealing audible alarm" and the display of the iabp indicated an "internal error" had occurred, the iabp was then swapped.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The supplier returned the power management board to the national repair center (nrc).The supplier stated that they could not verify the failure of internal error and failure codes of 67 and 107.The board passed testing.A senior repair technician inspected the power management board and no visual damage was observed.The technician then installed the power management board into the cardiosave test fixture and it tested to factory specifications per cardiosave service manual and it passed testing.The board will be packaged and labeled and sent to stock per procedure.

Event Description

It was reported that before use on a patient, the cardiosave intra-aortic balloon pump (iabp) was powered on and the iabp unit successfully completed all power on self tests.The iabp was then brought into the cath lab and left in "stand by" mode for approximately 5 minutes while patient was prepped.After approximately 5 minutes end user reported that the iabp emitted a "loud, squealing audible alarm" and the display of the iabp indicated an "internal error" had occurred, the iabp was then swapped.There was no patient involvement, and no adverse event reported.

Manufacturer Narrative

The power management board (pmb) was returned to getinge's national repair center (nrc) for investigation and inspection was completed per procedure, with no visual damage observed.The nrc installed the board into a cardiosave test fixture and tested the board to factory specifications per procedure and the cardiosave service manual.After extensive testing and evaluation, the nrc could not verify the failure of internal error or the error codes of 107 and 67 in the fault logs.The board passed testing and has been sent to the supplier per procedure.

• 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: 10101217
• MDR Text Key: 192732400
• Report Number: 2249723-2020-00828
• 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,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 05/06/2020
• Initial Date FDA Received: 05/29/2020
• Supplement Dates Manufacturer Received: 06/11/2020; 10/02/2020
• Supplement Dates FDA Received: 07/07/2020; 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1