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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 Connection Problem (2900); Gas Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/15/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The sample will not be returning.
 
Event Description
It was reported via a hot line call. The registered nurse (rn) called to troubleshoot the pump but the pump has already been exchanged prior to the call. The registered nurse wanted to try and fix the pump since this is their back-up now. There was less than 15 second delay while switching the pumps. The patient is supported on the second pump, with no alarms or issues and achieving the goals of therapy. The registered nurse stated that the helium tank gauge on the first pump was red. They exchanged the tank and now the new tank was red. The tank appears to be losing helium. There have been no other alarms or issues on the pump. No blood noted in the tubing. The registered nurse stated that they had this issue once before with a different patient. The clinical support specialist (css) verified that when the tank was exchanged they noted the helium indicator to be blue initially as sometimes people put the empties back. The registered nurse reported no audible leak. The tank connection was examined and appeared to be tight. The css discussed the o-ring in the yoke and helium could be escaping from there. The css suggested that they have their biomed check the pump since it is no longer on the patient. The registered nurse is also going to contact her local rep in case we have a service contract. The css explained that at this hour, she does not have access to that information. There were no additional calls.
 
Manufacturer Narrative
(b)(4). Teleflex did not receive the device for evaluation therefore the reported complaint of "leak in helium supply" could not be confirmed. The pump was serviced by field engineer and no problem was found with the pump. The root cause of the reported complaint is undetermined. A device history record (dhr) review was conducted for the serial and lot numbers with no relevant findings. The device passed all manufacturing specifications prior to release. This issue will be monitored for developing trends.
 
Event Description
It was reported via a hot line call. The registered nurse (rn) called to troubleshoot the pump but the pump has already been exchanged prior to the call. The rn wanted to try and fix the pump since this is their back-up now. There was less than 15 second delay while switching the pumps. The patient is supported on the second pump, with no alarms or issues and achieving the goals of therapy. The rn stated that the helium tank gauge on the first pump was red. They exchanged the tank and now the new tank was red. The tank appears to be losing helium. There have been no other alarms or issues on the pump. No blood noted in the tubing. The rn stated that they had this issue once before with a different patient. The clinical support specialist (css) verified that when the tank was exchanged they noted the helium indicator to be blue initially as sometimes people put the empties back. The rn reported no audible leak. The tank connection was examined and appeared to be tight. The css discussed the o-ring in the yoke and helium could be escaping from there. The css suggested that they have their biomed check the pump since it is no longer on the patient. The rn is also going to contact her local rep in case we have a service contract. The css explained that at this hour, she does not have access to that information. There were no additional 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
carmen sherman
16 elizabeth drive
chelmsford, MA 01824
9782505100
MDR Report Key6400904
MDR Text Key69868222
Report Number1219856-2017-00043
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 02/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberIAP-0500
Other Device ID Number00801902051714
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 Received04/05/2017
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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