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.

Manufacturer Narrative

The customer has decided to not repair the iabp unit.Confirmation was received that the iabp unit will be decommissioned.

Event Description

N/a.

Manufacturer Narrative

Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 24 month product complaint trend data for the period may 2019 through apr 2021 was reviewed.There were no triggers identified for the review period.

Event Description

N/a.

• 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: brian schaeffer ; 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
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 03/29/2022

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: Health Professional
• 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
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose