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

Model Number 0998-00-0800-45

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2023

Event Type  malfunction  

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) unit was making a loud high noise, and then the pump stopped and the message on the pump was a power up test failure code 4 and 5.The nurse called from the cvicu regarding these issues.He stated that he switched pumps 2x due to a loud high noise, then the pump stopped and the message on the pump was a power up test failure code 4 and 5.Since patient was hemodynamically stable, it was suggested to put the pump in standby and disconnect both ends of the helium extender tubing and empty the fluid in the sink or garbage.However, this step was done already.It was recommended he keep the extender tubing as horizontal as possible and minimize the dependent loop.The two pumps that had the loud noise and power up test failure code 4 & 5 were sequestered and sent to biomed.This report is for the is for the third pump, that the patient was on at the time of the call that had condensation built up in the tubing.There was no alarming/ noises or unexpected stopping of the pump.There was no patient harm reported.The first iabp (reference mfr report # 2249723-2023-03714) and the second iabp (reference mfr report # 2249723-2023-03726) that were switched out are being reported separately.

Manufacturer Narrative

A supplemental report will be submitted upon completion of our investigation.

Manufacturer Narrative

A getinge field service engineer(fse) was not dispatched to evaluate the unit as the customer has not requested evaluation and has not provided additional information at this time.Additional information has been requested regarding the evaluation and/or repair of the unit.If additional information is received a supplemental report will be submitted.Device not available for evaluation.

• Brand Name: CARDIOSAVE HYBRID, TYPE I 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 17585043
• MDR Text Key: 322412857
• Report Number: 2249723-2023-03769
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108421
• UDI-Public: 10607567108421
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-45
• Device Catalogue Number: 0998-00-0800-45
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 76 KG