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

Model Number N/A

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company 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 and determined that the front end board that the customer had ordered failed out of box.The stm replaced the front end board to resolve the issue, and as a troubleshooting measure during repair, the stm also replaced the pneumatic module assembly.The stm then performed all functional and safety tests to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported that during a preventive maintenance (pm) performed by the customer, the cardiosave intra-aortic balloon pump (iabp) was failing the autofill test.The customer found a broken test pin on the front end board.In order to correct the issue, the customer ordered and replaced the front end board, but after the front end board was replaced, the iabp was unable to pass the autofill calibration or autofill test.There was no patient involved and no adverse event reported.

Manufacturer Narrative

In order to correct the issue, the customer replaced the front end board.However, after front end board was replaced, the iabp was unable to pass the autofill calibration/test.The customer contacted getinge to request a repair visit.A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the iabp unit and found that the failure occurred due to an out of box (oob) failure of the front end board.The fse replaced the front end board that the biomedical engineer originally ordered and also replaced the pneumatic interface assembly as a troubleshooting measure.The fse completed full calibration, safety, and functionality checks completed per the service manual and all passed to factory specifications.

Event Description

It was reported that during a preventive maintenance (pm) of the cardiosave intra-aortic balloon pump (iabp), the customer discovered a broken test pin on the front end board.There was no patient involved and no adverse event reported.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• MDR Report Key: 7951269
• MDR Text Key: 123370496
• Report Number: 2249723-2018-01746
• 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
• Report Date: 11/09/2018

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: Other
• 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: 09/20/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 10/15/2018
• Supplement Dates FDA Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1