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

Model Number N/A

Device Problems Component Missing (2306); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2018

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) evaluated the iabp and confirmed that the unit showed 1/3rd full for the helium bottle, both digitally and analog displays and replaced the helium bottle with the customer's last known full bottle.The bottle was full and was indicated as full on both digital and analog displays.The stm then performed a helium leak check and the iabp only lost 1 psi over 5 minutes with a.04 degrees celsius change to ambient temperature.The stm was not sure as to why a new bottle that the catm replaced, was only 1/3rd full, but he advised the customer to get the bottles refilled since they were down to their last bottle.The stm was unable to confirm any errors with the helium display system and could not detect a leak in the helium system.The iabp passed all functional, safety, and electrical tests to factory specifications and was returned to the customer and cleared for clinical use.(b)(6).

Event Description

A getinge cardiac assist territory manager (catm) reported that during an in-service training , the cardiosave intra-aortic balloon pump (iabp) had a depleted helium bottle.The depleted helium bottle was replaced with a new bottle, but the iabp only showed 3/4ths full on the display.The catm reported that there was a possible helium leak and transducer failure.The customer also reported that they lost the iabps blood pressure transducer cable and pigtail cable.No patient was involved and no adverse event was reported.

• Brand Name: CARDIOSAVE
• 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: 7659459
• MDR Text Key: 113263201
• Report Number: 2249723-2018-01134
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

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: 06/19/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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