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 Death (1802)

Event Date 12/31/2017

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for this iabp unit cannot be reviewed per the sop since the serial number for the unit was not provided.To date, the customer has not provided the details of the involved pump.However, the customer has confirmed that the patient did not die from iabp failure, but that she did pass away from another complication several days following surgery.If additional information is provided, a supplemental report will be submitted.

Event Description

It was reported that on (b)(6) 2017, patient was transferred from (b)(6)facility with an unknown getinge intra-aortic balloon pump (iabp) in use, and the intra-aortic balloon (iab) was in situ.On (b)(6) 2017, the perfusionist was called by the bedside nurse who noticed frank blood present in the gas line.The perfusionist advised the registered nurse to put the iabp on standby, and the cvt was informed.The patient was then taken to the operating room (or) and the defective iab was removed without difficulty and a new iab was reinserted.It was reported that the patient later died, but the date of the death is unknown.The death is not attributed to the iabp.A separate report will be submitted for the involved iab.

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.Getinge service was not requested.However, the customer advised that no evaluation was performed, there was no failure of the iabp, and that it was used on the same patient post-op with no issues.The patient died several days later, and the iabp remains in clinical service.(b)(4).

Event Description

It was reported that on (b)(6) 2017, patient was transferred from windsor to lhsc facility with the cs300 intra-aortic balloon pump (iabp) in use, and the intra-aortic balloon (iab) was in situ.On (b)(6) 2017, the perfusionist was called by the bedside nurse who noticed frank blood present in the gas line.The perfusionist advised the registered nurse to put the iabp on standby, and the cvt was informed.The patient was then taken to the operating room (or) and the defective iab was removed without difficulty and a new iab was reinserted.It was reported that the patient later died, but the date of the death is unknown.The death is not attributed to the iabp.A separate report will be submitted for the involved iab.

• 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: 7305841
• MDR Text Key: 101256022
• Report Number: 2249723-2018-00316
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• 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-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 02/22/2018
• Date Device Manufactured: 09/28/2009
• 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): Death