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

Catalog Number IAP-0500

Device Problems Connection Problem (2900); Gas/Air 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.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: INTRA-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 Key: 6400904
• MDR Text Key: 69868222
• Report Number: 1219856-2017-00043
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2017
• 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: Unknown
• Patient Sequence Number: 1