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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Catalog Number IAP-0500J
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during inspection (prior to clinical use) the intra-aortic balloon pump (iabp) had a purge alarm.As a result, another iabp was used.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
(b)(4).No iabp part or recorder strip was returned for investigation.The reported complaint of iabp purge failure alarm is not able to be confirmed.No part has been returned to teleflex chelmsford for investigation.If the part is returned at a later date, an investigation of the part will be performed.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.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that during inspection (prior to clinical use) the intra-aortic balloon pump (iabp) had a purge alarm.As a result, another iabp was used.There was no report of patient complications, serious injury or death.
 
Manufacturer Narrative
Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of "purge failure alarm" is confirmed.The release spring inside the vent valve was found stuck which was the cause of the alarm.The root cause of how to release spring became stuck is determined.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 revived risk.This will be monitored for any developing trends.
 
Event Description
It was reported that during inspection (prior to clinical use) the intra-aortic balloon pump (iabp) had a purge alarm.As a result, another iabp was used.There was no report of patient complications, serious injury or death.
 
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Brand Name
AUTOCAT2 WAVE JAPANESE
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9278619
MDR Text Key183741319
Report Number3010532612-2019-00392
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberIAP-0500J
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Date Manufacturer Received02/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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