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

Model Number N/A

Device Problems Difficult to Insert (1316); Failure to Select Signal (1582); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed as per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge service territory manager (stm) was dispatched to investigate.The stm evaluated the iabp unit and confirmed the external ecg input was not functioning.Upon further evaluation, the stm found the input connector was loose.The stm removed the front end board, tightened the loose ecg connector, and reinstalled the front end board.Subsequently, the stm completed all safety, functionality, and calibration checks and all tests passed to factory specifications.The iabp unit was cleared for clinical use and released to the customer.

Event Description

It was reported that before use on a patient, there was an issue with the ecg port on the cardiosave intra-aortic balloon pump (iabp).It was later reported that a perfusionist was setting up for a case and connected the external ecg slave cable from the anesthesia cart to the iabp unit and was unable to see an ecg waveform.It was noted that the patient balloon was not inserted or connected to the iabp unit.The iabp unit was swapped out for another iabp unit to continue the setup without issue.There was no patient involved; thus, no adverse event reported.

• 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 07430
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 8444682
• MDR Text Key: 139714008
• Report Number: 2249723-2019-00454
• Device Sequence Number: 0
• Product Code: DSP
• Reporter Country Code: US
• 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
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• 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: 03/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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