MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number 0998-00-0800-53

Device Problems Device Contamination with Body Fluid (2317); Unexpected Shutdown (4019)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 04/18/2021

Event Type  Injury  

Manufacturer Narrative

A getinge field service engineer (fse) was dispatched to evaluate the iabp unit. Upon arrival at the customer's site, the fse attempted to turn on the iabp unit but it would not power on. The fse took pictures of all the boards and parts with visible blood contamination, and stated that for blood to enter and saturate the inside of iabp unit, blood would be visible through the iab tubing prior to entering the patient interface module and then the inside of the iabp console. As blood would start to enter the iabp unit through iab tubing, autofill alarms would be present. Per email from the customer, the end user ran the iabp until a system failure shutdown was present, caused by continued use of the iabp in which blood contamination spilled onto multiple internal boards. The iabp user manual describes the action that should have been taken by the operator. The fse concluded the reported event was caused due to user error. At this time, the customer has not requested for the iabp unit to be repaired as the fse has deemed the iabp unit a total loss. The iabp unit remains out of use pending a decision. A supplemental report will be submitted if additional information is provided.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump started alarming. The staff went into the patient's room to check the iabp unit and observed blood throughout the intra-aortic balloon (iab) tubing. A minute later, the iabp unit alarmed system failure and then turned off. The doctor was informed and cardiology was paged. The cardiology doctor attempted to pull out the iab, but the patient's blood pressure was observed to be a little high (sbp 160-170's). The patient was administered two doses of hydralazine. The doctor discontinued use of the iabp unit.

• Brand Name: CARDIOSAVE HYBRID TYPE B PLUG
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: dorota wolpiuk ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 11825146
• MDR Text Key: 251189483
• Report Number: 2249723-2021-01008
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• 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,Followup
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 05/14/2021 Patient Sequence Number: 1