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

Model Number N/A

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as 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 investigate.The stm noted that the balloon would fill all the way and when the iabp would start pumping it would fill the balloon all the way up, then three quarters of the way, then half way, then a quarter of the way, and then not at all.The whole time the stm could hear the iabp trying to pump up balloon and the compressor was making a loud noise.In addition, the stm found that when twisting power cord plug, the power led on the cart would turn off.The stm determined that this failure was related to a previous service call reported under mfg report# 2249723-2018-02117.To address the failures, the stm replaced the compressor, power cord assembly, and the filters.The stm noted that the compressor and the power cord assembly came from the customers stock.The stm then performed all calibration, functional and safety tests per factory specifications and due to the intermittent problems with this iabp unit, the stm instructed the customer to perform a "burn-in" and let the iabp run with a balloon and trainer for the rest of the week.The burn-in completed without issue, and the stm cleared the iabp for use and returned to the customer.

Event Description

It was reported that during a service/test performed by the customer, the cardiosave intra-aortic balloon pump (iabp) generated an autofill failure while burn-in with a balloon and trainer after a repair attempt.There was no patient involvement 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
• Manufacturer (Section G): DATASCOPE MAHWAH; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd.; mahwah, NJ 07430
• MDR Report Key: 8187696
• MDR Text Key: 131479360
• Report Number: 2249723-2018-02182
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1