MAUDE Adverse Event Report: DATASCOPE MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

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.There has been no reported malfunction of the iabp.If additional information is provided, we will submit a supplemental report.Full name of event site: (b)(6) medical center.

Event Description

It was reported that during cs300 intra-aortic balloon pump (iabp) therapy, the wave form became dampened.Customer assessed the line and found blood backed up into the helium line.The iabp was placed on standby and the intra-aortic balloon (iab) was removed.Pressure was applied for 20 minutes and a pressure dressing was applied and the patient developed a hematoma.The hematoma that formed began expanding towards his abdomen and additional pressure was applied and vascular surgery was consulted.The patient was then taken to the or for exploratory groin and subsequently underwent femoral artery closure.Indication for use was ischemia following cardiopulmonary bypass.The injury is not attributed to the iabp.Please refer to report on the intra-aortic balloon submitted under medwatch #2248146-2018-00607.

• Brand Name: CS300
• 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: 8025352
• MDR Text Key: 125750210
• Report Number: 2249723-2018-01882
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/09/2009
• 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): Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 98