MAUDE Adverse Event Report: DATASCOPE MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CS100

Device Problem Computer Operating System Problem (2898)

Patient Problem Death (1802)

Event Date 05/22/2016

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.The customer elected to evaluate the iabp and no blood was found on the iabp components and no other failure was reported.The iabp is back into service and is providing therapy to another patient without any issues.On the day of the event day the fault logs recorded autofill failures codes that are associated with "blood detected" alarms.

Event Description

The customer reported that while the iabp was in use on a patient, the iabp generated a "blood detected" alarm.20 minutes after the alarm the caregiver rebooted the iabp and the therapy continued without any problems.The caregiver took 20 minutes to reinitiate the therapy because he was trying to confirm there was no kink in the iab tubing or visual blood in the iab circuit.Thirty-six (36) minutes after the iabp was rebooted, the patient died.The customer caregiver (surgeon) is not attributing the patient's death to the pump event, however the hospital's safety management committee believes since the iab therapy was interrupted for 20 minutes, it might have contributed to the patient's death.The customer provided the pre-existent medical history of the patient: the patient was hospitalized in a different hospital under treatment for his leg, details of the disease is unknown.The patient suffered cardiopulmonary arrest twice in the past, and received resuscitation each time.When the patient was transferred to the hospital where the reported event occurred on (b)(6), the patient condition was ventricular fibrillation, and the surgeon was considering icd.On (b)(6) 2016, the patient was in cardiac arrest and was transferred from a different hospital; pcps was started and iab therapy also started.On (b)(6) 2016, pcps was weaned; iab therapy continued and external pacemaker was used.On (b)(6) 2016, the reported event occurred.

• Brand Name: CS100
• 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: 5728963
• MDR Text Key: 47516066
• Report Number: 2249723-2016-00019
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K031636
• 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
• Report Date: 05/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CS100
• Device Catalogue Number: 0998-00-3013-XX
• Other Device ID Number: SA06596-E7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 05/30/2016
• Date Device Manufactured: 05/29/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 65 YR