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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP Back to Search Results
Catalog Number IAP-0500
Device Problems Failure to Pump (1502); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via a hot line call. The rn calling to troubleshoot an "unable to refill alarm. " the (rn) registered nurse states the pump has been pumping well with no other issues. They have checked all the stated causes on the pump but "it just stopped pumping and won't pump. " the (css) clinical support specialist asked the rn how many alarms they have had and he stated this is the only alarm. The rn stated he pressed the reset button but "it is not working. " the css explained that a gas alarm is going to automatically go to the off position and discussed this alarm and possible causes with him. There is no noted blood in the tubing, all connections are intact and no kinks. The css told the rn that the pump will not resume pumping until they place it back in the pump status on position. The rn stated they had not attempted that. Once pumping was resumed (the rn stated pumping was only interrupted for a few minutes). The pump is pumping without issue. The pump is currently pumping and achieving the goals of therapy as reviewed with the rn. The alarm did not reoccur during the call. The css provided her direct number to the rn to call if he had any additional questions. The css received no more calls.
 
Manufacturer Narrative
Qn#(b)(4). No parts or recorder strips were returned to (b)(4) for evaluation. Per the hotline call, the rn stated that the pump got an unable to refill alarm. The css told the rn that the pump would not resume pumping until they place it back in the pump status on position. Once the rn placed the pump back on, the pump resumed pumping achieving the goals of therapy. This resolved the issue. The rn had no further questions. Note: the alarm "unable to refill" indicates failure to fill helium to target level 2. 5mmhg (usually after drain task). This alarm will cause the pump to stop pumping (pump off), deflate iab, open vent valve, audio alarm, alarm message, freeze w/form - prints out on strip. The specific serial number was not reported, but a device history record (dhr) review was conducted for all the lot numbers/serial numbers at this account with no relevant findings. All devices passed all manufacturing specifications prior to release. See other remarks section. Other remarks: conclusion: the reported complaint of "unable to refill alarm" is confirmed based on the information provided to the css. The css provided instructions to the rn in order to help manage the pump and provide the appropriate level of support to the patient. The pump was reset and this resolved the issue. No intra-aortic pump (iap) parts or recorder strips were returned for evaluation at the (b)(4) facility. The root cause of the reported complaint is undetermined.
 
Event Description
It was reported via a hot line call. The rn calling to troubleshoot an "unable to refill alarm. " the (rn) registered nurse states the pump has been pumping well with no other issues. They have checked all the stated causes on the pump but "it just stopped pumping and won't pump. " the (css) clinical support specialist asked the rn how many alarms they have had and he stated this is the only alarm. The rn stated he pressed the reset button but "it is not working. " the css explained that a gas alarm is going to automatically go to the off position and discussed this alarm and possible causes with him. There is no noted blood in the tubing, all connections are intact and no kinks. The css told the rn that the pump will not resume pumping until they place it back in the pump status on position. The rn stated they had not attempted that. Once pumping was resumed (the rn stated pumping was only interrupted for a few minutes). The pump is pumping without issue. The pump is currently pumping and achieving the goals of therapy as reviewed with the rn. The alarm did not reoccur during the call. The css provided her direct number to the rn to call if he had any additional questions. The css received no more calls.
 
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Brand NameAUTOCAT2 WAVE
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
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6058038
MDR Text Key58460550
Report Number1219856-2016-00250
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number30801902051715
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 Received11/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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