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

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/22/2017

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) unit was reviewed and no non-conformances related to the reported event were noted.This report has been sent per company protocol of co-reporting when the event description entails a serious injury or death regarding the iabp/ iab.However, further information has been requested from the customer regarding the iabp, and a supplemental report will be submitted if pertinent information is provided.

Event Description

A getinge engineer reported that via an email from the customer he was informed about a service on an iabp with blood in the disc.During a telephone call with the customer, the following was reported to the engineer: on (b)(6) 2017 at approximately 3.00 clock, the balloon was observed full of blood.The pressure gauge in the catheter was broken, and during the removal of the catheter, the fractured part was placed in the femoral artery, which necessitated surgery.The physician advised us that he would be reporting this incident to the authority.Refer to related complaint on the intra-aortic balloon catheter to be reported under trackwise #(b)(4).

Manufacturer Narrative

A getinge field service engineer (fse) evaluated the iabp and verified the presence of blood in the pump.The fse replaced all blood contaminated parts, then performed all functional and safety checks to factory specifications and released the iabp to the customer for clinical use.

Event Description

A getinge engineer reported that via an email from the customer he was informed about a service on an iabp with blood in the disc.During a telephone call with the customer, the following was reported to the engineer: on (b)(6) 2017 at approximately 3.00 clock, the balloon was observed full of blood.The pressure gauge in the catheter was broken, and during the removal of the catheter, the fractured part was placed in the femoral artery, which necessitated surgery.The physician advised us that he would be reporting this incident to the authority.Refer to related complaint on the intra-aortic balloon catheter to be reported under trackwise #(b)(4).

• 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: 7039978
• MDR Text Key: 92286363
• Report Number: 2249723-2017-00801
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-XX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2008
• 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): Required Intervention