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

Model Number N/A

Device Problems Device Contamination with Body Fluid (2317); Moisture or Humidity Problem (2986)

Patient Problems Pain (1994); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

The production device history record (dhr) for this intra-aortic balloon pump (iabp) was reviewed and no non-conformances related to the reported event were noted.Additional information has been requested and a supplemental report will be submitted if subsequent information is provided.(b)(6).Device evaluated by manufacturer? not returned to manufacturer.

Event Description

The following report was received via medwatch#: (b)(4).Event date: (b)(6) 2017.It was reported during cardiosave intra-aortic balloon (iab) therapy on a patient who was awaiting heart transplant, the bedside registered nurse (rn) noticed that the waveform on the iabp changed.The rn flushed the line and waveform returned momentarily.The waveform changed again and when the rn assessed the helium tubing, condensation and small specks of blood were found in the line.The coronary care unit team (ccu) was called to the bedside and at this time the amount of blood in the tubing increased.The iabp was put on standby and the helium tubing clamped.The patient reported pain and the cardiothoracic (ct) surgery team came to assess the patient.The intra aortic balloon catheter (iabc) was removed and the patient underwent right axillary artery repair.Please refer to mfg report number 2248146-2019-00894 for information on the involved iabc.

Manufacturer Narrative

The customer did not request getinge service in connection with this event, however, the hospital's risk management department has advised that she is fairly sure that the unit has been returned to service.

Event Description

The following report was received via medwatch# (b)(4): event date: (b)(6) 2017.It was reported during cardiosave intra-aortic balloon (iab) therapy on a patient who was awaiting heart transplant, the bedside registered nurse (rn) noticed that the waveform on the iabp changed.The rn flushed the line and waveform returned momentarily.The waveform changed again and when the rn assessed the helium tubing, condensation and small specks of blood were found in the line.The coronary care unit team (ccu) was called to the bedside and at this time the amount of blood in the tubing increased.The iabp was put on standby and the helium tubing clamped.The patient reported pain and the cardiothoracic (ct) surgery team came to assess the patient.The intra aortic balloon catheter (iabc) was removed and the patient underwent right axillary artery repair.The risk management dept.Has advised that it is unknown if the patient's adverse event was being attributed to the iabp.Please refer to mfg report number 2248146-2019-00894 for information on the involved iabc.

• 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
• MDR Report Key: 9386318
• MDR Text Key: 168302147
• Report Number: 2249723-2019-01924
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K112372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• 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?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRA-AORTIC BALLOON CATHETER; INTRA-AORTIC BALLOON CATHETER; INTRA-AORTIC BALLOON CATHETER
• Patient Outcome(s): Other
• Patient Weight: 69