MAUDE Adverse Event Report: ABIOMED, INC. IMPELLA; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Catalog Number 005062

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/26/2018

Event Type  Injury  

Event Description

Elderly male with past medical history (pmh) of cardiac and pulmonary sarcoidosis got admitted for cardiogenic shock with complaints of progressively worsening dyspnea, lower extremity edema as well as 15 pound weight gain.Diagnosed as combined systolic and diastolic cardiomyopathy with cardiogenic shock and oliguria.Impella 5.0 was placed via right axillary artery as a bridge to decision regarding vad candidacy.The next day: pt was working with ot and rn.While returning to bed, impella 5.0 cable became dislodged, as a result pt became hypotensive, attending provider and cv surgery team notified, epinephrine restarted, norepinephrine dose increased.Impella representative notified.New console and cables connected without return of function to pump.Clinical team were at the bedside.Pt stabilized with restarting epinephrine, increased norepinephrine.After cable disconnected, pump was no longer functioning.Pt returned to cardiovascular operating room (cvor), and had new impella placed.Prior to working with ot and during the session, position of securement device was verified by both ot and rn to ensure securement.It is unclear how cable became disconnected during repositioning.While connecting the device back, it appears the prongs inside of the gray connection cable was damaged.One side of the gray connection cable is connected to the impella inside of the patient and the other end is connected to the impella console.The prongs must have been damaged on the impella connection side because a new impella console cable was connected to the patient with no change and a new impella console was used as well.

• Brand Name: IMPELLA
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): ABIOMED, INC.; 22 cherry hill dr.; danvers MA 01923
• MDR Report Key: 8193716
• MDR Text Key: 131322314
• Report Number: 8193716
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/20/2018,11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 005062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 26280 DA
• Patient Weight: 111