Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
- Company
- Datascope Corp.
- Recall Initiated
- July 31, 2023
- Posted
- August 30, 2023
- Recall Number
- Z-2436-2023
- Quantity
- 9175 units
- Firm Location
- Mahwah, NJ
Reason for Recall
Users were reporting instances of "Gas Loss in IAB Circuit" and "Gas Gain in IAB Circuit" alarms while providing therapy. An internal investigation of the complaints determined that there is a potential trigger for these alarms that was not listed in the IFU: Patient Movement (coughing, general movement, and swallowing). Blood in the circuit, kinks/abrasions of the tubing/catheter and certain patient conditions could also trigger these alarms. The firm's HHE also identified hardware issues related to these alarms.
Distribution
Worldwide - US Nationwide distribution.
Lot / Code Info
All Lot Numbers. Model: 0998-00-0800-75, UDI: 10607567112312; Model: 0998-00-0800-83, UDI: 10607567108407; Model: 0998-00-0800-85, UDI: 10607567113449
Root Cause
Under Investigation by firm
Action Taken
An URGENT MEDICAL DEVICE CORRECTION notification letter dated 7/31/23 was sent to customers. Gas Loss & Gas Gain Alarms User Actions to be taken now: Our records indicate that you may have a Cardiosave Hybrid and/or Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) affected by this correction in your facility. Please examine your inventory immediately to determine if you have any Cardiosave Hybrid and/or Rescue IABPs. The following actions should be taken should you experience an alarm for Gas Loss in IAB & Gas Gain in IAB : Gas Gain in IAB Circuit " Verify all of the tubing connections are leak free. " Press the START key to initiate an Autofill and resume pumping. Gas Loss in IAB Circuit " Inspect the tubing from the patient through to the connection of the helium extender tubing to the female luer port of the Cardiosave IABP. " If any blood is noted or perforation is suspected, the following procedure must be performed immediately: 1. Disconnect the catheter extender tubing from the IABP console to allow the balloon to deflate. 2. Clamp extracorporeal tubing between white y-fitting and male connector. 3. Place patient in Trendelenburg as tolerated to guide any residual helium to travel away from the head vessels. 4. Notify physician, and prepare for IAB catheter removal. 5. Consider IAB catheter replacement, if the patient s condition warrants. 6. If blood is suspected of having entered the pump, take pump out of service. It should be evaluated before use in another patient by a Getinge or Biomed/Technical Service representative who has been trained on Cardiosave service requirements, to determine if replacement of contaminated components is necessary. " If blood is not detected, ensure that the IAB extender tubing is tightly connected to the IAB and the IABP. If appropriate, perform an Autofill by pressing and holding the IAB FILL key for 2 seconds, then press the START key to resume pumping. " If the patient is febrile or tachycardic, consider increasi