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

Catalog Number IAP-0700

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the field service engineer (fse) that the cursor on the intra-aortic balloon pump (iabp) was stuck and would not move. Issue occurred during use on patient and the pump was swapped out. The fse could not reproduce the symptom. The iabp checked out okay. There was no report of patient harm or injury.

Manufacturer Narrative

(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "the cursor being stuck" is not able to be confirmed. The field service agent serviced the pump and no issues was found. The root cause of the complaint is undetermined. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. The reported complaint will be monitored for any developing trends. No further action required at this time.

Event Description

It was reported by the field service engineer (fse) that the cursor on the intra-aortic balloon pump (iabp) was stuck and would not move. Issue occurred during use on patient and the pump was swapped out. The fse could not reproduce the symptom. The iabp checked out okay. There was no report of patient harm or injury.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7978263
• MDR Text Key: 124128348
• Report Number: 3010532612-2018-00315
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902084965
• UDI-Public: 00801902084965
• Combination Product (y/n): N
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No