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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT2 WAVE ITALIAN; SYSTEM, BALLOON, INTRA-AORTIC
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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE ITALIAN; SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Model Number IPN000320
Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983); Noise, Audible (3273)
Patient Problem No Information (3190)
Event Date 07/28/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a high baseline alarm while on patient and it was noted the pump assembly was "noisy".As a result, the iabp was swapped out for another iabp.There was no information regarding patient outcome.
 
Manufacturer Narrative
(b)(4).Teleflex received the device for investigation.The reported complaint of "high baseline alarm" is confirmed.The pump alarmed high baseline (1) during the complaint investigation.An excessive noise was noted from the pump assembly consistent with a motor/lead screw malfunction.The root cause of this 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 revived risk.This will be monitored for any developing trends.The "brand name" has been updated accordingly from an "autocat2 wave" to an "autocat2 wave italian".
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) had a high baseline alarm while on patient and it was noted the pump assembly was "noisy".As a result, the iabp was swapped out for another iabp.There was no information regarding patient outcome.
 
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Brand Name
AUTOCAT2 WAVE ITALIAN
Type of Device
SYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10431522
MDR Text Key203681421
Report Number3010532612-2020-00219
Device Sequence Number1
Product Code DSP
UDI-Device Identifier30801902092190
UDI-Public30801902092190
Combination Product (y/n)N
PMA/PMN Number
K162820
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN000320
Device Catalogue NumberIAP-0500I
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/14/2020
Date Manufacturer Received09/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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