MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 JAPANESE; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number	IAP-0400J
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the user called the dealer's call center to report a purge 3 alarm that occurred during use.The intra-aortic balloon pump (iabp) could not detect an electrocardiogram.As a result, the iabp was replaced by a back-up one.There was no patient death, serious injury or complications reported.Patient outcome reported as good.
Additional Manufacturer Narrative
(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "purge failure alarm" is not able to be confirmed; the distributor's technician checked the pump and could not replicate the purge failure alarm.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.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 or Problem Description
It was reported that the user called the dealer's call center to report a purge 3 alarm that occurred during use.The intra-aortic balloon pump (iabp) could not detect an electrocardiogram.As a result, the iabp was replaced by a back-up one.There was no patient death, serious injury or complications reported.Patient outcome reported as good.

• Brand Name: AUTOCAT2 JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8084870
• Report Number: 3010532612-2018-00338
• Device Sequence Number: 19232214
• Product Code: DSP
• UDI-Device Identifier: 00801902043412
• UDI-Public: 00801902043412
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K060309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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-0400J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1