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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 Connection Problem (2900)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) didn't detect the intra-aortic balloon (iab) catheter after insertion and therefore the iabp was replaced by a backup one. (the inserted catheter was used as it is. ) then, the therapy was continued without problem. The iabp in question was tested using another iab catheter and the same issue did not reoccur. There was no patient death, serious injury or patient complication reported. Additional information received. After connected the driveline tubing to the inserted iab catheter, the user plugged the console volume connector of tubing in the pump; however the pump didn't recognize the iab catheter.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for investigation. The reported complaint of "connection difficulty" cannot be confirmed; however, the field technician checked and no problem was found with the pump. 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. No further action required at this time.
 
Event Description
It was reported that the intra-aortic balloon pump (iabp) didn't detect the intra-aortic balloon (iab) catheter after insertion and therefore the iabp was replaced by a backup one. (the inserted catheter was used as it is. ) then, the therapy was continued without problem. The iabp in question was tested using another iab catheter and the same issue did not reoccur. There was no patient death, serious injury or patient complication reported. Additional information received. After connected the driveline tubing to the inserted iab catheter, the user plugged the console volume connector of tubing in the pump; however the pump didn't recognize the iab catheter.
 
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Brand NameAUTOCAT2 WAVE JAPANESE
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
16 elizabeth drive
chelmsford MA 01824
Manufacturer Contact
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key7403027
MDR Text Key104822772
Report Number3010532612-2018-00063
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500J
Other Device ID Number00801902043429
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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