MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number N/A

Device Problems Loose or Intermittent Connection (1371); Output below Specifications (3004)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was not required to be reviewed per company standard operating procedure since the device manufacture date is greater than one year from the event date.A getinge field service engineer (fse) evaluated the iabp and during an initial external inspection it was seen that the safety disk/condensate removal module was loose.Part was refitted properly and machine powered up - no alarm appeared.Equipment was then put through a basic service in order to confirm pressure/vacuum values.Equipment failed autofill calibration with a value of 49mmhg.Bimba cylinder was adjusted and retested - new value of 100mmhg.Equipment put through a final function test.All functional and safety tests were passed to meet factory specifications, and the iabp was returned to the customer and cleared for clinical service.

Event Description

It was reported that prior to use a "low vacuum alarm" had appeared on a cs300 intra-aortic balloon pump (iabp).Due to the current pandemic crisis it was asked that the machine be removed from current location, cleaned, and quarantined for engineers visit.Upon cleaning the machine on tuesday (b)(6) 2020, it was noticed by the perfusion staff that the gas reservoir was sitting loose.When refitted the machine was turned back on and the alarm failed to show.There was no patient involvement and no adverse event was reported.

• Brand Name: CS300
• 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: 10083221
• MDR Text Key: 193432646
• Report Number: 2249723-2020-00785
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 0998-00-3023-53
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2018
• 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