MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number CARDIOSAVE HYBRID

Device Problems No Display/Image (1183); Fluid Leak (1250); Loss of Power (1475)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

The rn was just outside the door and heard an unusual sound. She entered the room and saw the screen had gone black, pump was off and a large puddle was on the floor. Anesthesia was close by to support the patient with medication until a replacement machine could be set up. About 450 of the 500 ml bag spilled onto the back of the machine where the ecg and pressure cables connect and then pooled on the floor. We are guessing that a connection in the transducer tubing came loose and since the heparin was inside a pressure bag at 300mmhg it likely suddenly gushed onto the back of the machine. Machine was brought to clinical engineering for evaluation. Manufacturer field service tech opened the machine and found traces of fluid in several spots inside the machine. It appears fluid reached the power supply board, causing the machine to shut down. See attached photos. The ingress protection rating of this machine is specified as ipx0 (no protection against ingress of water). Power supply board was replaced and unit returned to service. Manufacturer response for intraorrtic balloon pump, datascope (per site reporter). Manufacturer field service tech evaluated and repaired the machine.

Event Description

The rn was just outside the door and heard an unusual sound. She entered the room and saw the screen had gone black, pump was off and a large puddle was on the floor. Anesthesia was close by to support the patient with medication until a replacement machine could be set up. About 450 of the 500 ml bag spilled onto the back of the machine where the ecg and pressure cables connect and then pooled on the floor. We are guessing that a connection in the transducer tubing came loose and since the heparin was inside a pressure bag at 300mmhg it likely suddenly gushed onto the back of the machine. Machine was brought to clinical engineering for evaluation. Manufacturer field service tech opened the machine and found traces of fluid in several spots inside the machine. It appears fluid reached the power supply board, causing the machine to shut down. The ingress protection rating of this machine is specified as ipx0 (no protection against ingress of water). Power supply board was replaced and unit returned to service. Manufacturer response for intraorrtic balloon pump, datascope (per site reporter). Manufacturer field service tech evaluated and repaired the machine.

• Brand Name: CARDIOSAVE HYBRID
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 13591024
• MDR Text Key: 286077363
• Report Number: 13591024
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/09/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CARDIOSAVE HYBRID
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2022
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown