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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500J
Device Problem Device Alarm System (1012)
Patient Problem Glaucoma (1875)
Event Date 02/22/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device / parts will not be returned for evaluation.
 
Event Description
It was reported that at 14:00 on (b)(6) 2016 the intra-aortic balloon (iab) catheter was inserted via the patient's left femoral artery using a teflon sheath. Soon after placement of the catheter, drain failure occurred and the alarm went off; however, drainage was not confirmed in the bottle. At 17:00, the alarm stopped however a little drainage was confirmed in the drain bottle. At 19:00, the pump was replaced by a new one. There was no reported patient death, injury or complications. There was no reported delay or interruption in therapy. Medical / surgical intervention was not required. The patient outcome is listed as good. Reference mdr #1219856-2016-00058 for the second event and mdr #1219856-2016-00059 for the third event involving the same patient.
 
Manufacturer Narrative
Qn#(b)(4). Device evaluation: no intra-aortic balloon pump parts or recorder strips were returned for evaluation at the (b)(4) facility. The pump was serviced by our certified distributor in (b)(4). The drain failure alarms could not be reproduced. All cables were disconnected and reconnected as such to the cpu (central processing unit) pcb (printed circuit board). No problem was found with the pump related to the reported complaint. A functional check was performed and the pump passed all testing. The drain failure message is an alert. Drain failure alerts do not interrupt pumping or impede the function of the pump. A device history record review was conducted for the iabp serial and lot number with no relevant findings. The device passed all manufacturing specifications prior to release. The software revision was noted as 2. 23. Conclusion: the reported complaint of "drain failure" is confirmed. The pump was checked by our certified distributor in (b)(4) and the drain failure alarms could not be reproduced on the pump. The cause of the drain failure could not be determined.
 
Event Description
It was reported that at 14:00 on (b)(6) 2016 the intra-aortic balloon (iab) catheter was inserted via the patient's left femoral artery using a teflon sheath. Soon after placement of the catheter, drain failure occurred and the alarm went off; however, drainage was not confirmed in the bottle. At 17:00, the alarm stopped however a little drainage was confirmed in the drain bottle. At 19:00, the pump was replaced by a new one. There was no reported patient death, injury or complications. There was no reported delay or interruption in therapy. Medical / surgical intervention was not required. The patient outcome is listed as good. Reference mdr #1219856-2016-00058 for the second event and mdr #1219856-2016-00059 for the third event involving the same patient.
 
Manufacturer Narrative
Qn#(b)(4). Corrected data: investigation conclusion verbiage corrected to state "the reported complaint of "drain failure is not confirmed".
 
Event Description
It was reported that at 14:00 on (b)(6) 2016 the intra-aortic balloon (iab) catheter was inserted via the patient's left femoral artery using a teflon sheath. Soon after placement of the catheter, drain failure occurred and the alarm went off; however, drainage was not confirmed in the bottle. At 17:00, the alarm stopped however a little drainage was confirmed in the drain bottle. At 19:00, the pump was replaced by a new one. There was no reported patient death, injury or complications. There was no reported delay or interruption in therapy. Medical / surgical intervention was not required. The patient outcome is listed as good. Reference mdr #1219856-2016-00058 for the second event and mdr #1219856-2016-00059 for the third event involving the same patient.
 
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Brand NameAUTOCAT2 WAVE JAPANESE
Type of DeviceINTRA-AORTIC BALLOON PUMP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
kathryn myers
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key5484024
MDR Text Key39799940
Report Number1219856-2016-00056
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
Type of Report Initial,Followup,Followup
Report Date 02/22/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500J
Other Device ID Number30801902043420
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 Received04/22/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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