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

Model Number IPN001112

Device Problem Failure to Run on Battery (1466)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

B)(4).Other remarks: after the iabp was removed from patient, the iabp was sent to bio-med.The field service engineer (fse) was called in and replaced the battery.The fse performed preventative maintenance (pm) and the iabp passed pm and functional checks.

Event Description

It was reported that the battery doesn't keep a charge resulting in the intra-aortic balloon pump (iabp) shutting off.As a result, the iabp was plugged back in and worked fine.There was no report of patient complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of "the battery does not keep a charge resulting in the pump shutting off" is confirmed.During the investigation, the returned battery shut off the pump after approximately 25 minutes when operating on battery power.A definitive root cause could not be determined but a potential cause of the short battery life is a result of maintaining of the battery.Iabp users and servicers must follow the operating instructions manual for recommendations on usage, charging, maintenance and storage of the batteries.If battery maintenance is not performed per the iabp operating instructions manual, the battery may not provide the expected minimum run time of operating power.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.Other remarks: after the iabp was removed from patient, the iabp was sent to bio-med.The field service engineer (fse) was called in and replaced the battery.The fse performed preventative maintenance (pm) and the iabp passed pm and functional checks.

Event Description

It was reported that the battery doesn't keep a charge resulting in the intra-aortic balloon pump (iabp) shutting off.As a result, the iabp was plugged back in and worked fine.There was no report of patient complications, serious injury or death.

• 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: 9944498
• MDR Text Key: 187195591
• Report Number: 3010532612-2020-00097
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 30801902084966
• UDI-Public: 30801902084966
• 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: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN001112
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1