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

Catalog Number	IAP-0500J
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the intra-aortic balloon pump (iabp) switched to battery power despite being plugged in while in use.As a result, the iabp was swapped out for another iabp.There was no report of patient complications, serious injury or death.
Additional Manufacturer Narrative
(b)(4).No iabp part was returned to teleflex chelmsford for investigation.The reported complaint of "the iabp was switched to be battery-powered despite it being plugged" is not able to be confirmed.The iabp was tested by a distributor's technician and the issue could not be replicated.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the iap serial and lot 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 revived risk.This will be monitored for any developing trends.
Event or Problem Description
It was reported that the intra-aortic balloon pump (iabp) switched to battery power despite being plugged in while in use.As a result, the iabp was swapped out for another iabp.There was no report of patient complications, serious injury or death.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10454306
• Report Number: 3010532612-2020-00240
• Device Sequence Number: 16947935
• Product Code: DSP
• UDI-Device Identifier: 00801902043429
• UDI-Public: 00801902043429
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2020

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-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1