MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AEROAUTOCAT2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0435
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that while on a patient the unit stopped pumping and had to cycle power 5 times to get pump to resume pumping.There were no patient complications reported.The fields service engineer (fse) could not reproduce the reported problem with operation.There were no reports of patient consequence.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "iabp shut off in use" is not able to be confirmed.The device was checked by a teleflex field service engineer and passed functional checkout.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.The reported complaint will be monitored for any developing trends.No further action required at this time.
Event or Problem Description
It was reported that while on a patient the unit stopped pumping and had to cycle power 5 times to get pump to resume pumping.There were no patient complications reported.The fields service engineer (fse) could not reproduce the reported problem with operation.There were no reports of patient consequence.

• Brand Name: AEROAUTOCAT2
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7898851
• Report Number: 3010532612-2018-00296
• Device Sequence Number: 1395058
• Product Code: DSP
• UDI-Device Identifier: 00801902051745
• UDI-Public: 00801902051745
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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-0435
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1