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

Catalog Number 0998-00-0800-53

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per the company standard operating procedure since the device manufacture date is greater than one year from the event date.Additional information has been requested, and we will report accordingly if it becomes available.

Event Description

Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected".The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used.The second iabp experienced the same alarm and is being reported separately.No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.

Manufacturer Narrative

The customer biomed reported that he checked the error logs of the cardiosave intra-aortic balloon pump (iabp) and found the alarm documented in the logs.But the biomed could not find any issues causing the error.The biomed connected the iabp to the simulator for testing, disconnected the balloon and the iabp alarmed appropriately.He then checked all the connections and ran the iabp on simulator for several hours with no problems.The iabp was then returned to service.

Event Description

Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected".The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used.The second iabp experienced the same alarm and is being reported separately.No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.

Manufacturer Narrative

Corrected: (serial number from (b)(4) to (b)(4)).The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.

Event Description

Facility perfusionist reported that while in use on a patient the cardiosave intra-aortic balloon pump (iabp) falsely alarmed ¿iab disconnected".The perfusionist replaced the iabp and assured that all helium connections were secure and that the correct helium extension tubing was used.The second iabp experienced the same alarm and is being reported separately.No death or injury was reported but the customer did report there was a delay in therapy as they had to switch machines which caused some patient instability.

• 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: 7054718
• MDR Text Key: 92834623
• Report Number: 2249723-2017-00863
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 87 YR