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

Catalog Number 0998-00-3023-53

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Brain Injury (2219)

Event Date 04/21/2016

Event Type  Death  

Manufacturer Narrative

The production device history record (dhr) for the iabp involved in the event was reviewed.There were no nonconformance noted in the dhr related to the reported event.The customer has requested service of the unit (cs300 iabp, s/n (b)(4)) involved in the event and as reported in this medwatch.The company service department has initiated contact with the customer to arrange for service of the unit.The customer has requested service of the unit (cs300 iabp, s/n (b)(4)) involved in the event and as reported in this medwatch.The company service department has initiated contact with the customer to arrange for service of the unit.The production device history record (dhr) for the iabp involved in the event was reviewed.There were no nonconformances noted in the dhr related to the reported event.(b)(4).

Event Description

It was initially reported by the customer that the unit would be generating an alarm for ¿gas loss¿ when in fact no leaks were detected by the customer and it was found that all connection were secure.The device was rebooted and worked per specifications, and used to complete therapy.On 10/07/2016 when the company representative called back to the customer to obtain additional information, the customer reported the patient had suffered ¿brain death¿.The customer did not provide any information on whether the brain death of the patient is attributed to the device or to the event.The unit has not been utilized in therapy since the event.

Manufacturer Narrative

As previously stated, multiple attempts were made to the customer to retrieve information regarding the patient and to retrieve a confirmation of the event, but were unsuccessful.Other individuals within the same department and who were contacted did not recollect any such event (i.E.Unit malfunction and patient adverse event).Further, the customer requested service on the unit allegedly involved in the event, and a full preventive maintenance (pm) was performed by the company service representative.The outcome of the pm revealed the unit was fully functional and conformed to factory specifications.The unit was returned to the customer for use.

Event Description

It was initially reported by the customer that the unit would be generating an alarm for ¿gas loss¿ when in fact no leaks were detected by the customer and it was found that all connection were secure.The device was rebooted and worked per specifications, and used to complete therapy.On (b)(6) 2016 when the company representative called back to the customer to obtain additional information, the customer reported the patient had suffered ¿brain death¿.The customer did not provide any information on whether the brain death of the patient is attributed to the device or to the event.The unit has not been utilized in therapy since the event.Multiple attempts were made to the customer to retrieve information regarding the patient and to retrieve a confirmation of the event, but were unsuccessful.Other individuals within the same department and who were contacted did not recollect any such event (i.E.Unit malfunction and patient adverse event).

Manufacturer Narrative

During follow up communication between the company representative and the customer, the customer reported that the patient did not experience an adverse event and there was no patient death associated with the device.The patient is currently on a transplant list.No further information was provided.

Event Description

It was initially reported by the customer that the unit would be generating an alarm for ¿gas loss¿ when in fact no leaks were detected by the customer and it was found that all connection were secure.The device was rebooted and worked per specifications, and used to complete therapy.On 10/07/2016 when the company representative called back to the customer to obtain additional information, the customer reported the patient had suffered ¿brain death¿.The customer did not provide any information on whether the brain death of the patient is attributed to the device or to the event.The unit has not been utilized in therapy since the event.Multiple attempts were made to the customer to retrieve information regarding the patient and to retrieve a confirmation of the event, but were unsuccessful.Other individuals within the same department and who were contacted did not recollect any such event (i.E.Unit malfunction and patient adverse event).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP (IABP)
• 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: 6062652
• MDR Text Key: 58599908
• Report Number: 2249723-2016-00032
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2003
• 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
• Patient Age: 42 YR