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 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No sample components were returned for investigation.

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cardiac care unit(ccu) to assist troubleshoot persistent high baseline alarms.This is the only type of alarm that has occurred on the pump but is occurring approximately every 5-10 minutes at least, sometimes more frequently.The pump is otherwise achieving the goals of therapy in 1:1.On discussion, the rn reports that the alarms started after the iab was repositioned by the md.They felt that it was high and repositioned it slightly lower.They have ordered another chest x-ray to verify placement.Patient is 71 inches tall, no adipose tissue at the insertion site.No kinks were noted in the line or at the insertion site and no blood was noted in the catheter tubing.The clinical support specialist discussed with the rn an attempt to change patient positioning with no change.The css had the rn decrease the volume in the iab with no change in the alarm status.Catheter gas line disconnected, reconnected and pumping resumed with no change in status.After discussion, the css suggested that they exchange the pump.After exchanging the pump, the alarm did not reoccur.Multiple calls back and forth and last call at 0815 est the patient was supported on the second pump without alarms or issues.The first pump was sent to biomed for examination.

Manufacturer Narrative

(b)(4).No iabp parts or recorder strips were returned to teleflex (b)(4) for evaluation.Per the hotline call, the rn was calling to troubleshoot persistent high baseline alarms.The css discussed repositioning the patient and decreasing the volume with no change in the status.However, the pump was otherwise achieving the goals of therapy.As a result, the pump was exchanged.No further alarms were received.Per the field service engineer: this is a demand customer.The account has a trained biomed and they do their own repair.The fse was unaware and was not contacted regarding any issue related to the reported complaint.Follow up information received from the hospital biomed stated that the pump was sent to the biomed department.The hospital biomed checked out the pump and could not duplicate the alarm issue.The pump was returned to service on 08/04/2016.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.See other remarks section.Other remarks: conclusion: the reported complaint of "high baseline alarm" is not confirmed.The pump was checked by the hospital biomed and no problem was found related to the reported complaint.No parts will be returned to teleflex (b)(4) facility for evaluation.The cause of the reported complaint could not be determined.

Event Description

It was reported via a hotline call from the registered nurse (rn) in the cardiac care unit(ccu) to assist troubleshoot persistent high baseline alarms.This is the only type of alarm that has occurred on the pump but is occurring approximately every 5-10 minutes at least, sometimes more frequently.The pump is otherwise achieving the goals of therapy in 1:1.On discussion, the rn reports that the alarms started after the iab was repositioned by the md.They felt that it was high and repositioned it slightly lower.They have ordered another chest x-ray to verify placement.Patient is (b)(6), no adipose tissue at the insertion site.No kinks were noted in the line or at the insertion site and no blood was noted in the catheter tubing.The clinical support specialist discussed with the rn an attempt to change patient positioning with no change.The css had the rn decrease the volume in the iab with no change in the alarm status.Catheter gas line disconnected, reconnected and pumping resumed with no change in status.After discussion, the css suggested that they exchange the pump.After exchanging the pump, the alarm did not reoccur.Multiple calls back and forth and last call at 0815 est the patient was supported on the second pump without alarms or issues.The first pump was sent to biomed for examination.

• 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: 5896890
• MDR Text Key: 52779047
• Report Number: 1219856-2016-00187
• 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: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500
• Device Lot Number: 0001078912
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2007
• 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