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

Model Number N/A

Device Problems Calibration Problem (2890); Device Operates Differently Than Expected (2913)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.A getinge field service engineer (fse) evaluated the iabp and performed running test in getinge office, and the reported incident was not duplicated.The iabp worked normally and all functional and safety tests were passed per factory specifications, thus no parts were replaced.The iabp was returned to the customer and has been released for clinical use.

Event Description

It was reported that after the intra-aortic balloon (iab) was inserted into a cardiopulmonary arrest patient, the optical sensor was unable to take the arterial pressure since the catheter was located in the patient.Although attempts were made to connect it with the sensor connector, it was unable to take a calibration.The cardiosave iabp was replaced with a cs100 to continue therapy; however, the arterial pressure was unreadable.The surgeon had an impression of the catheter failure, and used the monitor kit from another line to measure arterial pressure instead of the optical sensor.Three days later they removed the iab and discontinued iabp therapy.No patient harm or adverse event was reported.

Manufacturer Narrative

Correction of date in initial mdr: please note that the date in the initial mdr was erroneously reported as (b)(4) 2018 but should read (b)(4) 2018.

Event Description

It was reported that after the intra-aortic balloon (iab) was inserted into a cardiopulmonary arrest patient, the optical sensor was unable to take the arterial pressure since the catheter was located in the patient.Although attempts were made to connect it with the sensor connector, it was unable to take a calibration.The cardiosave iabp was replaced with a cs100 to continue therapy; however, the arterial pressure was unreadable.The surgeon had an impression of the catheter failure, and used the monitor kit from another line to measure arterial pressure instead of the optical sensor.Three days later they removed the iab and discontinued iabp therapy.No patient harm or adverse event was reported.

• Brand Name: CARDIOSAVE
• 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: 7580888
• MDR Text Key: 110630466
• Report Number: 2249723-2018-00967
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112372
• 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: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-0800-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: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• 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 Weight: 60