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

Model Number	IPN000325
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "the pump had been used from july 5.On july 10 at 14:16, the code 26 alarm went off.The alarm sound stopped by pushing the reset button, but it went off again after 20 - 30 min.There was a turbid liquid about 1/3 in the bottle.The liquid was drained, but the alarm went off again.About 3 mm of liquid accumulated in 3 hours after the liquid was drained.The catheter was operating without any problems.At 15:13, blood came into the catheter.The pump was replaced with a new one".Additional received stated that the catheter was a non-teleflex device.Patient condition "unknown" at time of report.
Additional Manufacturer Narrative
Qn# (b)(4).The reported complaint of "alarm went off" is not able to be confirmed.The sample and recorder strip was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release.The root cause of the complaint is undetermined.No further action required at this time.The reported complaint will be monitored for any developing trends.
Event or Problem Description
It was reported that "the pump had been used from july 5.On july 10 at 14:16, the code 26 alarm went off.The alarm sound stopped by pushing the reset button, but it went off again after 20 - 30 min.There was a turbid liquid about 1/3 in the bottle.The liquid was drained, but the alarm went off again.About 3 mm of liquid accumulated in 3 hours after the liquid was drained.The catheter was operating without any problems.At 15:13, blood came into the catheter.The pump was replaced with a new one".Additional received stated that the catheter was a non-teleflex device.Patient condition "unknown" at time of report.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 15208908
• Report Number: 3010532612-2022-00300
• Device Sequence Number: 14615591
• Product Code: DSP
• UDI-Device Identifier: 30801902043420
• UDI-Public: 30801902043420
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Device Model Number: IPN000325
• Device Catalogue Number: IAP-0500J
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/11/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CATHETER; CATHETER
• Patient Sex: Unknown