MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE INTRA-AORTIC PUMP; INTRA-AORTIC BALLOON PUMP

Model Number CARDIOSAVE

Device Problems Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Ventricular Fibrillation (2130)

Event Date 02/24/2014

Event Type  Death  

Event Description

Customer said cardiosave stopped triggering while on patient then started to trigger a while later.Stm called biomed, who said they were able to get the pump to trigger after they did a "push" of volume and eppi.The patient has deceased.Patient coded in the operating room on (b)(6) 2014, resuscitated, put back on pump.It appears by the log strips that the unit was in automode, ecg trigger, from 11 pm on (b)(6) 2014 to 6:10 am on (b)(6) 2014 without any issue.At 6:10 am, (b)(6) 2014, the pump switched to bp trigger and from that point the pump was switching from bp trigger to ecg trigger to pacer a trigger and also internal trigger.Noted at some time during this period the pump was put in the semi-auto mode.The customer said the patient had runs of 4-5 vfibs.The last trigger event was with the pump in the pacer v trigger at 7:44:40 am.The patient did code and deceased.Maquet was not contacted by hospital, during the no caps incident.

Manufacturer Narrative

Evaluation summary: the 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.Service report: error logs strips have been sent to pssd complaints dept.It was found by the technician that the reported problem could not be duplicated.(b)(4).

• Brand Name: CARDIOSAVE INTRA-AORTIC PUMP
• Type of Device: INTRA-AORTIC BALLOON PUMP
• Manufacturer (Section D): DATASCOPE CORP.; fairfield NJ
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd.; mahwah NJ 07430
• Manufacturer Contact: janice pevide, manager ; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 4106482
• MDR Text Key: 14875580
• Report Number: 2249723-2014-00172
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CARDIOSAVE
• Device Catalogue Number: 0998-00-0800-XX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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 Age: 80 YR