MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS100; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Atrial Fibrillation (1729); Low Blood Pressure/ Hypotension (1914)

Event Date 03/24/2019

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) of the intra-aortic balloon pump (iabp) involved in the event was reviewed.There were no non-conformances in the production dhr related to the reported event.A getinge field service engineer (fse) evaluated the iabp and all testing passed.It was determined that the alarm during the event was related to the augmentation settings and the patient¿s poor condition.Based on the clinical situation, and review of the event logs, the alarms seem reasonable; this was the final time in the ot as the staff was getting ready for surgery and bypass.After confirming that the iabp was operating correctly, the getinge sales representative and clinical trainer contacted the customer to offer advice in case of similar experiences in the future.No parts were replaced; therefore, no further investigation is required.

Event Description

It was reported that a competitor¿s intra-aortic balloon (iab) was inserted distally into the patient in the cath lab.During patient transport to the operating theatre (ot) while on the cs100 intra-aortic balloon pump (iabp), the patient blood pressure dropped from 110 to below 60.The patient went into a-fibrillation and crashed.The iabp began to emit an augmentation alarm.Cpr was administered to the patient and the patient was transferred to the operating theatre.It was reported that the attending perfusionist was frustrated with the alarm on the cs100, cags and arrow fiber optic balloon inserted.The patient was reportedly stable and in the icu.The customer requested that getinge evaluate the iabp due to the alarming during use.It was later suspected that the balloon was not inserted correctly and/or moved on transfer.It is suspected that the issue was due to the patient¿s condition (very unstable and very low bp) and not a pump related issue.

• Brand Name: CS100
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8530058
• MDR Text Key: 142463905
• Report Number: 2249723-2019-00628
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K031636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2019
• 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: 0998-00-3013-64
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2007
• 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