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

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).For related events on the same patient see mdr #3010532612-2019-00061 and tc # (b)(4), mdr #3010532612-2019-00062 and tc # (b)(4), mdr #3010532612-2019-00063 and tc# (b)(4).

Event Description

It was reported by the registered nurse (rn) that the, touchscreen of the intra-aortic balloon pump (iabp) was frozen.The clinical support specialist (css) had the rn verify that the touchscreen was unlocked, and the staff attempted to lock and unlock multiple times with no change.The hard keys are still functioning, and the pump is pumping without interruption.The css had the rn change the ratio, use the cursor, the hard keys are working but no change is reflected on the screen.The rn power reset the pump with no change in frozen screen.As a result, the pump was swapped out for another.There was a report of patient death.The rn reported that the patient had an ejection fraction of 12% and was not a surgical candidate.The device did not cause or contribute to the patient's death.

Manufacturer Narrative

(b)(4).For related events on the same patient see mdr #3010532612-2019-00061 and tc #1900066633, mdr #3010532612-2019-00062 and tc #1900066634, mdr #3010532612-2019-00063 and tc #1900066635.Teleflex received the device for investigation.The reported complaint of "frozen screen" is not confirmed.The returned cpm board and front end board passed visual and functional test specifications.The root cause of the complaint is undetermined.No further action required at this time.

Event Description

It was reported by the registered nurse (rn) that the, touchscreen of the intra-aortic balloon pump (iabp) was frozen.The clinical support specialist (css) had the rn verify that the touchscreen was unlocked, and the staff attempted to lock and unlock multiple times with no change.The hard keys are still functioning, and the pump is pumping without interruption.The css had the rn change the ratio, use the cursor, the hard keys are working but no change is reflected on the screen.The rn power reset the pump with no change in frozen screen.As a result, the pump was swapped out for another.There was a report of patient death.The rn reported that the patient had an ejection fraction of 12% and was not a surgical candidate.The device did not cause or contribute to the patient's 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: 8428796
• MDR Text Key: 139081755
• Report Number: 3010532612-2019-00085
• 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: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/18/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1