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 Problem Failure to Sense (1559)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Testing of actual/suspected device: (10/213) at this time, the customer has not requested getinge to evaluate the iabp unit involved in this event.Attempts to communicate with the customer have been made to obtain further repair information.A supplement report will be submitted should additional information be provided.

Event Description

It was reported that the cardiosave intra-aortic balloon pump (iabp) had no pressure indices on display, the iabp was restarted postop and was pumping appropriately.Troubleshooting revealed that there was a loss of the arterial waveform.No patient harm, serious injury or adverse event was reported.

Manufacturer Narrative

Updated fields: b4, g4, g7, h2, h10, h11.Corrected fields: b6, b7, h10.Device not accessible for testing (4117): at this time, the customer has not requested getinge to evaluate the iabp unit involved in this event.Attempts to communicate with the customer have been made to obtain further repair information.A supplement report will be submitted should additional information be provided.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Iit was reported that the cardiosave intra-aortic balloon pump (iabp) had no pressure indices on display, the iabp was restarted post-op and was pumping appropriately.Troubleshooting revealed that there was a loss of the arterial waveform.No patient harm, serious injury or adverse event was reported.A getinge field service engineer called to report that there were no pressure indices displayed on the cardiosave in the cvor.The pump had been restarted post-op and was pumping appropriately.Troubleshooting revealed that there was also no arterial pressure waveform present on the pump.The source was labeled fiberoptic.Reseating the fo plug did not result in the appearance of a waveform.There currently was no clinical reason to prevent calibration.A calibration was invoked which was not successful, since there is no visible arterial waveform.He will transduce the radial line for blood pressures as an alternate source.No additional information available.Three (3) gfe attempts have been performed to obtain additional event information.No response has been provided, the complaint will be closed and in the event new information was to become available, this record will be reopened and updated.H3 other text : customer didn't request for repair service.

• 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: 12137596
• MDR Text Key: 263601142
• Report Number: 2249723-2021-01458
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: 10607567108391
• Combination Product (y/n): N
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/08/2021
• Supplement Dates Manufacturer Received: 08/05/2021; 03/02/2024
• Supplement Dates FDA Received: 08/31/2021; 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN.
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 70 KG