MAUDE Adverse Event Report: TELEFLEX INCORPORATED AC3 OPTIMUS IABP; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Device Problems Defective Component (2292); Blocked Connection (2888); Calibration Problem (2890)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2021

Event Type  malfunction  

Event Description

When it was determined the surgeon wanted to insert an intra aortic balloon (iab) catheter in the patient, an intra aortic balloon pump (iabp) was brought into the or.When the perfusionist tried to attach the fiber optic calibration device of the iab catheter it would not lock into the iabp as expected.Further more the iabp would not recognize the calibration device and initiate the fiber optic calibration process.At this point another perfusionist went out to retrieve a second iabp.When the iab fiberoptic device was inserted into the second iabp it would not lock into place once again.At this point it was decided that the original iabp would be used and there would be no fiber optic pressure capability.Upon further inspection by the perfusionist, it appeared that the fiber optic calibration receptacles might have been faulty on both iabp's.Both the manufacturer's rep and biomedical engineering were notified of the problem and made aware that there was potentially two devices in question.The device serial numbers were communicated to biomedical engineering.

• Brand Name: AC3 OPTIMUS IABP
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11776264
• MDR Text Key: 249027413
• Report Number: 11776264
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA