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

Catalog Number IAP-0700

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the pump a3 delivering therapy via fiber-optic intra-aortic balloon (iab) stopped pumping.The screen went black suddenly and the pump shut down and attempt to restart x five failed.Strip generated first time saying "purge failure sub code 3".Then on further attempts to re-start the print strip generated saying "purge failure-sub code 8" four further times.Pump exchanged for different a3 pump which started immediately with no further problems during therapy.First pump, which stopped was removed.The perfusionist was advised to leave this pump out of patient use until it could be examined by an engineer.There was no reported patient death or complications.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "the pump stopped pumping and the screen went black" is not confirmed.The distributor "hugo technology" serviced the pump and no problem was found with the pump.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.

Event Description

It was reported that the pump a3 delivering therapy via fiber-optic intra-aortic balloon (iab) stopped pumping.The screen went black suddenly and the pump shut down and attempt to restart x five failed.Strip generated first time saying "purge failure sub code 3".Then on further attempts to re-start the print strip generated saying "purge failure-sub code 8" four further times.Pump exchanged for different a3 pump which started immediately with no further problems during therapy.First pump, which stopped was removed.The perfusionist was advised to leave this pump out of patient use until it could be examined by an engineer.There was no reported patient death or complications.

• 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: 6914470
• MDR Text Key: 88236073
• Report Number: 1219856-2017-00219
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Other Device ID Number: 00801902084965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• 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: Unknown
• Patient Sequence Number: 1