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

Catalog Number 0998-00-0800-53

Device Problem Backflow (1064)

Patient Problem Death (1802)

Event Date 02/24/2017

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 noted in the dhr related to the reported event.

Event Description

While in use on a patient a malfunction occurred with iabp #1 (ca247907f4).Then a second iabp (ca247622f4) was brought in to continue therapy.This event description is for the second iabp (ca247622f4) delivering therapy.The customer reported that within minutes of use on the patient, blood became visible in the tubing all the way back to the iabp.Therapy was immediately stopped, and catheter was removed.There was no replacement for therapy as the patient was doing "ok" without assistance.On, march 24, 2017, getinge was notified that the patient expired on (b)(6) 2017.The customer reported that the patient's death is not being attributed to the iabp.Furthermore, an additional report is being submitted with the information regarding the intra-aortic balloon (under trackwise number (b)(4)), and the information regarding the intra-aortic balloon pump #1(under trackwise number (b)(4)).

• Brand Name: CARDIOSAVE 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: 6444713
• MDR Text Key: 71201332
• Report Number: 2249723-2017-00013
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0998-00-0800-53
• Other Device ID Number: CA247622F4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/24/2017
• Date Device Manufactured: 07/01/2014
• 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
• Treatment: SENSATION PLUS 8FR. 50CC IAB
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 89