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

Catalog Number IAP-0500

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No components were returned to date.

Event Description

It was reported via a hot line call.The registered nurse (rn) is calling to report a possible helium loss alarm (2 in the operating rom and 1 in intensive care unit).They have since changed the pump out for a second pump ((b)(4)).No blood is present in the driveline and the pump has not alarmed since switching to the second one.The rn and clinical support specialist (css)c discussed that there could be a small hole in the membrane and they need to be very diligent in checking the tubing over time and with any subsequent alarms.The rn verbalized understanding and the css discussed some other possible causes for the alarm, one of which is a leak internally in the first pump.The css suggested that the first pump ((b)(4)) be sent to biomed to be checked for any leaks internally.The css received no future calls.

Manufacturer Narrative

(b)(4).No iabp parts or recorder strips were returned to teleflex (b)(4) for evaluation.It has been reported that the pump alarmed "helium loss alarms".This alarm indicates that there may be a leak in tubing and connections, blood in catheter, kinked catheter, or ectopic beats.After the css discussed the possible causes for the alarm, the css suggested sending the pump to biomed to be checked out.Additional follow up information received from the hospital biomed stated that the pump was not sent to the biomed department.The biomed had nothing in his database related to the call report.The (wws) world wide support database was also checked and there was no further service provided to the pump related to the reported call report.Device history record (dhr) review was conducted for the iap serial and lot number with no relevant findings.The device passed all manufacturing specifications prior to release.The reported complaint of "helium leak alarm" is not confirmed.The pump was not sent to the biomed department.The wws database was also checked and there was no further service provided to the pump related to the reported call report.The cause of reported complaint is undetermined.

Event Description

It was reported via a hot line call.The registered nurse (rn) is calling to report a possible helium loss alarm (2 in the operating rom and 1 in intensive care unit).They have since changed the pump out for a second pump (s/n (b)(4).No blood is present in the driveline and the pump has not alarmed since switching to the second one.The rn and clinical support specialist (css)c discussed that there could be a small hole in the membrane and they need to be very diligent in checking the tubing over time and with any subsequent alarms.The rn verbalized understanding and the css discussed some other possible causes for the alarm, one of which is a leak internally in the first pump.The css suggested that the first pump (s/n (b)(4) be sent to biomed to be checked for any leaks internally.The css received no future 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: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 6071451
• MDR Text Key: 58937685
• Report Number: 1219856-2016-00235
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

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: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 11/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• 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: Unknown
• Patient Sequence Number: 1