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

Model Number 0998-00-0800-53

Device Problems Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/10/2021

Event Type  Death  

Manufacturer Narrative

Device not accessible for testing: device is not accessible for testing due to the customer not requesting repair service.A supplemental report will be submitted upon receipt of additional information.Not returned to manufacturer.

Event Description

It was reported that during use on a patient, the cardiosave intra-aortic balloon pump (iabp) generated a restriction alarm.The end user resumed pumping via the "start" key and an "internal communication failure" was then generated.The intra-aortic balloon (iab) had been inserted emergently and at the time therapy was initiated, the patient was deemed critical and was currently receiving chest compressions by a mechanical cpr device.The patient did not survive.The physician has verbalized that the "malfunction of the iabp did not change the patient outcome." this complaint is to document the second iabp unit involved in this event.

Manufacturer Narrative

Updated fields: e1 (event site name).Corrected fields: h6 (type of investigation).Testing of actual/suspected device (10/3233): a getinge field service engineer (fse) was dispatched to investigate.The fse inspected the iabp unit and during the diagnostic testing, found that the k10 transducer in the pneumatic module assembly was not reading the pressure.The fse ordered the necessary parts then returned at a later date to complete repairs.The fse installed the pneumatic module assembly then completed performance testing to ensure correct performance with no issues.Subsequently, the fse completed a full preventative maintenance (pm) service including 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.It is expected that the suspected faulty pneumatic module assembly will be returned to getinge's national repair center for failure analysis.A supplemental report will be submitted when additional information is provided.

Event Description

N/a.

Manufacturer Narrative

The following investigation was performed by the technician of the (b)(4).The national repair center (nrc) installed the pneumatic module assembly into the cardiosave test fixture and tested the pneumatic module assembly to factory specifications per procedure number and the cardiosave service manual.The nrc verified the failure of the pneumatic module assembly failing the 30 psi pressure transducer calibration.Unable to hold 30 psi.Retaining the pneumatic module assembly in the nrc per procedure (b)(4) rev aj.

• 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
• Manufacturer (Section G): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• Manufacturer Contact: arelean guzman ; 1300 macarthur blvd; mahwah, NJ
• MDR Report Key: 13121495
• MDR Text Key: 283077338
• Report Number: 2249723-2021-03011
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0998-00-0800-53
• 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: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON.; MECHANICAL CPR DEVICE.
• Patient Outcome(s): Death
• Patient Sex: Prefer Not To Disclose