MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT 2 WAVE; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0535
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by the field service engineer (fse) that "while on patient the display would freeze and go blank while pressing keys on the monitor.The intra-aortic balloon pump (iabp) was swapped and the patient was not harmed.After the swap, cath lab tried running the pump on the simulator and received "unable to refill" alarm error message." the fse found while pumping with the customer's balloon simulator, abnormal balloon waveform and clicking sound then "unable to refill" alarm.The fse also found this balloon simulator not properly inflated.Properly inflating the balloon simulator fixed the problem.Could not replicate screen freezing to ensure successful repair.The display umbilical cord is replaced.The iabp performed to specification.There was no reported patient death, serious injury or complications.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "black screen when the buttons is pressed" is not confirmed.Although, the root cause of the complaint could not be determined the returned display head cable passed visual and functional test specifications.No further action required at this time.
Event or Problem Description
It was reported by the field service engineer (fse) that "while on patient the display would freeze and go blank while pressing keys on the monitor.The intra-aortic balloon pump (iabp) was swapped and the patient was not harmed.After the swap, cath lab tried running the pump on the simulator and received "unable to refill" alarm error message." additional info/service findings: the fse found while pumping with the customer's balloon simulator, abnormal balloon waveform and clicking sound then "unable to refill" alarm.The fse also found this balloon simulator not properly inflated.Properly inflating the balloon simulator fixed the problem.Could not replicate screen freezing to ensure successful repair.The display umbilical cord is replaced.The iabp performed to specification.There was no reported patient death, serious injury or complications.
Event or Problem Description
It was reported by the field service engineer (fse) that "while on patient the display would freeze and go blank while pressing keys on the monitor.The intra-aortic balloon pump (iabp) was swapped and the patient was not harmed.After the swap, cath lab tried running the pump on the simulator and received "unable to refill" alarm error message." additional info/service findings: the fse found while pumping with the customer's balloon simulator, abnormal balloon waveform and clicking sound then "unable to refill" alarm.The fse also found this balloon simulator not properly inflated.Properly inflating the balloon simulator fixed the problem.Could not replicate screen freezing to ensure successful repair.The display umbilical cord is replaced.The iabp performed to specification.There was no reported patient death, serious injury or complications.
Additional Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "black screen when the buttons is pressed" is not confirmed.Although, the root cause of the complaint could not be determined the returned display head cable passed visual and functional test specifications.No further action required at this time.

• Brand Name: AEROAUTOCAT 2 WAVE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7744901
• Report Number: 3010532612-2018-00239
• Device Sequence Number: 1365813
• Product Code: DSP
• UDI-Device Identifier: 00801902051738
• UDI-Public: 00801902051738
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: IAP-0535
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 07/09/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 09/05/2018; 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1