FDA Adverse Event Injury Summary report: N

TELEFLEX MEDICAL AC3 OPTIMUS INTRA AORTIC BALLOON PUMP

MDR report key: 24702500 · Received March 26, 2026

Report

Report Number
MW5185978
Event Type
Injury
Date Received
March 26, 2026
Date of Event
February 14, 2026
Report Date
March 23, 2026
Manufacturer
TELEFLEX INCORPORATED
Product Code
DSP
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
RISK MANAGER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

UPON RECEIVING THE PATIENT VIA SHIFT REPORT, PATIENT WAS STABLE HEMODYNAMICALLY ON TELEFLEX IABP WITHOUT COMPLICATIONS UNTIL 02:00. UPON ASSESSING THE IABP SITE DURING ROUTINE HOURLY (AND MORE OFTEN WHILE IN ROOM) SITE CHECKS, AND RETRIEVING PRINTED IABP REPORT, I NOTED THAT THERE WAS A SMALL AMOUNT OF BLOOD (~10 ML) ON THE WHITE UNDERPAD OF THE PATIENT NEAR THE GROIN. WHILE CHECKING THE SITE I NOTICED THAT THE ARTERIAL PRESSURE SENSING LINE TO THE IABP WAS NOT ATTACHED TO THE PATIENT. UPON EXAMINING THE DEVICE SCREEN, THE AUGMENTED PRESSURE OF THE PATIENT DID NOT MATCH THE RADIAL ARTERIAL WAVEFORM OR MEASUREMENTS. THERE WAS A SMALL TRICKLE OF BLOOD COMING FROM THE RIGHT FEMORAL ARTERIAL CONNECTION OF THE IABP AND QUICKLY GOT ANOTHER NURSE TO EXAMINE THIS WITH ME ((B)(6)). (B)(6) THEN IMMEDIATELY GOT CARDIOLOGY FNP (B)(6) CARRIER AND (B)(6) ATTENDING - (B)(6) INTO THE ROOM TO LOOK AT THE DEVICE. UPON IMMEDIATE DISCOVERY THERE WERE PROVIDERS AT BEDSIDE AND NOTIFIED OF THE ISSUE AT HAND. REMI, MD, NOTED THAT THERE WAS A PIECE OF THE ARTERIAL TUBING (MALE SIDE) MISSING FROM THE UNATTACHED SECTION. WHILE LOOKING AT THE SITE CARRIER, FNP AND (B)(6) NOTED THAT THERE WAS NO POSSIBLE WAY TO REMOVE THIS PLASTIC PART FROM THE INLET OF THE DEVICE WITHOUT REMOVAL AND CHANGING THE IABP ENTIRELY. (B)(6) WAS NOTIFIED OF THIS DISCOVERY AND THE PATIENT BEING HEMODYNAMICALLY STABLE. IN ALL THERE WAS ~20 ML BLOOD LOSS FROM THE SMALL TRICKLE OF THE SITE. (B)(6) WAS NOTIFIED OF THIS ON THE PHONE AND STATED TO CHANGE IABP TO RATIO 1:2 (CHANGE OF 1:1). (B)(6) STATED THAT IF THE PATIENT IS HEMODYNAMICALLY STABLE, TO LEAVE IABP IN PLACE UNLESS (B)(6) CAN REMOVE AT THIS TIME. NEITHER PROVIDERS AT THE BEDSIDE WERE ABLE TO REMOVE THE IABP, AS THIS HAS TO BE A CARDIOLOGY ATTENDING OR CT SURGEON. (B)(6) STATED TO LEAVE IABP IN PLACE UNTIL 06:00 WHEN IT WOULD BE REMOVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
756379 TELEFLEX MEDICAL AC3 OPTIMUS INTRA AORTIC BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP TELEFLEX INCORPORATED AC3 OPTIMUS

Patients

Seq Age Sex Outcome Treatment
1 69 YR Male Required Intervention