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

Catalog Number IAP-0500J

Device Problems No Audible Alarm (1019); Device Contamination with Body Fluid (2317)

Patient Problem Glaucoma (1875)

Event Date 02/22/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device / parts will not be returned for evaluation.

Event Description

Reference mdr #1219856-2016-00056 for the first event and mdr #1219856-2016-00059 for the third event involving the same patient.It was reported that at 19:00 on (b)(6) 2016 the intra-aortic balloon pump (iabp) was placed, replacing the first iabp ((b)(4)) successfully.At 07:40 on (b)(6) 2016 the intra-aortic balloon (iab) catheter and iabp were removed.The patient had received iabp therapy for approximately 61 hours.There was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.Medical / surgical intervention was not required.The patient outcome is listed as good.At 17:00 the clinical engineer (ce) checked the removed iab catheter and found two ruptures on the catheter; however, it was unknown when the ruptures occurred.The rn stated that the pump did not alarm during the procedure.Additional information received stated that after the procedure the ce found dirty drainage in the bottle.

Manufacturer Narrative

(b)(4) device evaluation: no intra-aortic balloon pump (iabp) parts or recorder strips were returned for evaluation at the teleflex (b)(4) facility.It was reported that, blood backed up into the drainage bottle of the pump due to an intra-aortic balloon (iab) that had ruptured.Teleflex (b)(4) checked the pump and replaced all contaminated parts.Blood can only enter the iabp from an iab that develops a leak.The instructions for use (ifu) state, "intra-aortic balloon membrane perforation may occur during iabp therapy.The occurrence and severity of the iab perforation is unpredictable and may be due to patient physiology, accidental contact with a sharp instrument or by contact with calcified plaque resulting in membrane surface abrasion and eventual perforation.Large perforations are rare.Small perforations can result in asymptomatic release of gas.Perforation can cause blood to appear in the balloon catheter and driveline tubing." the ifu also states, "if you suspect balloon perforation: immediately stop pumping.Consider tapering or discontinuing anticoagulation therapy.Remove iab from patient, using recommended removal technique." see other remarks section for continuation.Other remarks: the alarm system is designed to alarm for small losses of helium.There must be a minimal loss of helium to generate a helium loss alarm.In this case the loss of helium may have been below the threshold for the alarm and therefore no alarm was generated.A device history record review was conducted for the iabp, pump assembly and interface block serial/lot numbers with no relevant findings.The devices passed all manufacturing specifications prior to release.The software revision level is 2.24ja.Conclusion: the reported complaint of blood found in the drainage bottle of the pump is confirmed.The iabp was checked by teleflex (b)(4).The pump assembly and related contaminated parts were replaced due to blood contamination.The cause of the damaged pump was the result of a catheter/balloon leak.

Event Description

Reference mdr #1219856-2016-00056 for the first event and mdr #1219856-2016-00059 for the third event involving the same patient.It was reported that at 19:00 on (b)(6) 2016 the intra-aortic balloon pump (iabp) was placed, replacing the first iabp ((b)(4)) successfully.At 07:40 on (b)(6) 2016 the intra-aortic balloon (iab) catheter and iabp were removed.The patient had received iabp therapy for approximately 61 hours.There was no reported patient death, injury or complications.There was no reported delay or interruption in therapy.Medical / surgical intervention was not required.The patient outcome is listed as good.At 17:00 the clinical engineer (ce) checked the removed iab catheter and found two ruptures on the catheter; however, it was unknown when the ruptures occurred.The rn stated that the pump did not alarm during the procedure.Additional information received stated that after the procedure the ce found dirty drainage in the bottle.

• Brand Name: AUTOCAT2 WAVE JAPANESE
• 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: kathryn myers ; 2400 bernville road; reading, PA 19605 ; 6103780131
• MDR Report Key: 5484099
• MDR Text Key: 39801631
• Report Number: 1219856-2016-00058
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K060309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0500J
• Other Device ID Number: 30801902043420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 69 YR
• Patient Weight: 55