MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0700

Device Problems Failure to Calibrate (2440); Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the fiber optic sensor (fos) was reconnected to the intra-aortic balloon pump (iabp) and tones were heard, but there was no signal. The pump continued to read "fos not connected". After multiple attempts to calibrate (cal) the mean arterial pressure (map), the clinical support specialist (css) had the rn unplug the fos and cal key to allow the pump to use the transducer. The pump was showing a waveform according to the rn, but still showed fos. After a second call it was determined that the pump monitor never showed fos, but the rn was reading it on the ap menu screen. The rn swapped out the pump and was able to switch consoles and the fos still was not connecting. As a result, the transducer was used without issue and the pump was giving appropriate support to the patient. There was no report of patient complication or serious injury and death.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7466573
• MDR Text Key: 106715323
• Report Number: 3010532612-2018-00099
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/31/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0700
• Other Device ID Number: 00801902084965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown