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

Catalog Number 0998-00-3013-XX

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem Death (1802)

Event Date 08/18/2016

Event Type  Death  

Manufacturer Narrative

The unit was evaluated by both the company field service engineer (fse) and the customer service representative. A review of the fault logs revealed there were no errors related to the event. It was also reported the issue with the iabp console appeared to have been with the on/off switch (p/n 0012-00-0834) and which was replaced. Further, it was also reported the batteries utilized by the customer are non-maquet batteries. A test of the batteries revealed they would fail the run time test. The batteries were replaced as well. The unit was safety and functional tested. All tests revealed the unit met specifications. The manufacturer is requesting the on/off switch (p/n 0012-00-0834) to be returned for further evaluation.

Event Description

Customer reported: iabp console shut down unexpectedly twice during use/therapy. It was also reported, the iabp console and catheter were replaced after patient received emergency surgery. In addition, the customer is not attributing the patient death to the device.

Manufacturer Narrative

The 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. Further, it was reported by the customer there would be no patient information available per their policy and the replaced power on/off switch (p/n 0012-00-0834) has been discarded. No further investigation can be performed. Updated: date received by mfr, type of reports, if follow-up, what type?, evaluation codes, additional mfr narrative.

Event Description

Customer reported: iabp console shut down unexpectedly twice during use/therapy. It was also reported, the iabp console and catheter were replaced after patient received emergency surgery. In addition, the customer is not attributing the patient death to the device.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP
• 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: 5961598
• MDR Text Key: 55096638
• Report Number: 2249723-2016-00027
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 08/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0998-00-3013-XX
• Other Device ID Number: SA02777-G4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: YR
• Event Location: No Information
• Date Manufacturer Received: 09/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 09/19/2016 Patient Sequence Number: 1