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

Catalog Number IAP-0700

Device Problems No Device Output (1435); Pumping Stopped (1503)

Patient Problems Arrhythmia (1721); Death (1802); No Consequences Or Impact To Patient (2199)

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) suddenly stopped without any alarm even when ecg readings were available.The pump stopped twice as a result, the pump had to be reset.There was a report of patient death.Dr.(b)(6) made the medical judgement that the patient's death was not caused or contributed by the device.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of iabp would not start pumping is not confirmed.A certified technician inspected the pump and no functional issues were noted.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot 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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) suddenly stopped without any alarm even when ecg readings were available.The pump stopped twice as a result, the pump had to be reset.There was a report of patient death.Dr.(b)(6) made the medical judgement that the patient's death was not caused or contributed by the device.

• 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: 8270954
• MDR Text Key: 133864769
• Report Number: 3010532612-2019-00008
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 79