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

Catalog Number 0998-00-3023-53

Device Problems Backflow (1064); Hole In Material (1293); Material Rupture (1546)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/22/2017

Event Type  Injury  

Manufacturer Narrative

The first name of the initial reporter has been abbreviated due to character limit; the full name should read (b)(6).The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) was dispatched to investigate.Failure of "blood back" was observed by the end user.The fse evaluated the iabp unit and was unable to reproduce the reported issue.He tested the cs300 iabp and observed no evidence of blood contamination and no blood detect logged in the fault journal.The fse observed some condensation in the pneumatic system, cleared it as per the protocol, and replaced the missing top cover concealment.The fse then performed all functional and safety tests per factory specifications, and the iabp passed all tests and was returned to customer and cleared for clinical use.

Event Description

Customer reported a blood back related incident occurred on the intra-aortic balloon pump from a ruptured balloon.This event occurred while in use on a patient, and a serious injury resulted to the patient per the balloon complaint referenced below.Furthermore, this report is related to balloon complaint which was reported under medwatch reference number 2248146-2017-00300 in which the following was reported: clinical staff noticed iabp systolic/diastolic number to be trending down.The insertion site noted to be bleeding, and patient was on heparin drip.Blood was also noted in the tubing/catheter of the balloon pump and upon removal of the iabp catheter, a hole was noted in the iabp catheter by the clinical staff.There was serious injury to the patient in this case but the facility does not attribute the injury to the device.

• Brand Name: CS300
• 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: 6798707
• MDR Text Key: 82859606
• Report Number: 2249723-2017-00300
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• 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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2011
• 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): Life Threatening; Required Intervention