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

Catalog Number IAP-0500

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported via a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling to discuss a few drain failure alarms.The patient is in normal sinus rhythm (nsr) rate in the 60's.The alarm has occurred a few times in about 2.5hours.There is minimal fluid in the condensation bottle.The clinical support specialist suggested they change the pump and send this one to biomed when they are able as it may be a sticking valve occasionally.The css reassured the nurse that therapy is not affected by this alarm.The in house perfusionist is going to come to the unit and assist when he/she is out of an emergent case in the or.Once changed to another pump, she will make a note of the issue for biomed.The pump alarmed 4 alarms in 2.5 hrs.The software 2.24.Additional information received on 10/14/2016: pump was exchanged off the patient.There was no reported patient death, injury or complications.

Manufacturer Narrative

(b)(4).No iap parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility.Additional information received from the field service engineer (fse) stated that the pump was taken off the patient and sent to the biomed.The pump worked fine for the biomed.The fse worked with the biomed and determined that the pump was ok and returned to service.The drain failure message is an alert.Drain failure alerts do not interrupt pumping or impede the function of the pump.The pump functioned as design.The iabp software revision is 2.24.A device history record (dhr) review was conducted for the iap serial number and lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of "drain failure alarms" is not confirmed.The pump was sent to the hospital biomed.The hospital biomed worked with the field service engineer and checked the pump out.The biomed determined the pump was operational and returned the pump to service.No iap parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility.The cause of the reported complaint is undetermined.

Event Description

It was reported via a hot line call.The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling to discuss a few drain failure alarms.The patient is in normal sinus rhythm (nsr) rate in the 60's.The alarm has occurred a few times in about 2.5 hours.There is minimal fluid in the condensation bottle.The clinical support specialist suggested they change the pump and send this one to biomed when they are able as it may be a sticking valve occasionally.The css reassured the nurse that therapy is not affected by this alarm.The in house perfusionist is going to come to the unit and assist when he/she is out of an emergent case in the operating room.Once changed to another pump, she will make a note of the issue for biomed.The pump alarmed 4 alarms in 2.5 hrs.The software 2.24.Additional information received on 10/14/2016: pump was exchanged off the patient.There was no reported patient death, injury or complications.

• 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: 6079246
• MDR Text Key: 59224559
• Report Number: 1219856-2016-00241
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/08/2016

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2016
• Initial Date FDA Received: 11/04/2016
• 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