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

Catalog Number IAP-0500

Device Problem Fitting Problem (2183)

Patient Problems Myocardial Infarction (1969); No Consequences Or Impact To Patient (2199)

Event Date 10/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4). No components have been returned to the manufacturer.

Event Description

It was reported via a hot line call. The registered nurse (rn) from the cardiac intensive care unit (cicu) is calling because they were getting the low helium tank pressure alarm and attempted to change the helium tank. The pump has been in use for a week. To change the helium tank, they had released the clamp holding the adaptor for the disposable tanks and removed the tank and adaptor. They changed the tank and replaced it. The rn stated that she heard a "whooshing" sound, and the pump again alarmed for purge failure when they attempted to turn it back on. This is when they called the hotline. The pump has otherwise been performing as expected. The rn stated that it has been about 5 minutes since the pump was last pumping. The clinical support specialist explained to the rn that the o-ring that seals the connection between the pump and the adaptor had most likely fallen out. The rn told the css that they have not been able to locate anything that looks like the ring that the css described to them. The css recommended that while they are looking for this they should also get another pump ready. The rn stated that they had already sent someone to get another pump. They had not found the o-ring before the other pump arrived, so they moved all connections to the pump that just arrived. It has now been 25 minutes since the pump was last running, and the css explained to the rn, that 30 minutes is the longest you can go without pumping the balloon. The rn verified that it has indeed been about 25 minutes and not more than 30 minutes. They then resumed pumping, and the new pump is now supporting the patient well. The css recommended that they have biomed check out the original pump.

Manufacturer Narrative

Qn#(b)(4). No intra-aortic balloon pump (iabp) parts were returned to the teleflex (b)(4) facility for evaluation. Additional information received from the hospital biomed stated that the pump was not serviced for the reported call report. However, the pump was serviced 11/30/16 by the field service engineer and a preventative maintenance was performed. The pump passed all testing. The pump was returned to service. There was no further service provided to the pump and no parts replaced. A device history record (dhr) review was conducted for the iabp lot number/serial 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 "low helium tank pressure alarms" is confirmed based on the information provided by the clinical support specialist (css). The css explained the possible causes of the helium tank issues and recommended sending the pump to biomed to be checked. A preventative maintenance was performed on the pump by the field service engineer and the pump passed all testing. No problem was found with the pump. No part or recorder strips were returned to teleflex (b)(4) for evaluation. 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 because they were getting the low helium tank pressure alarm and attempted to change the helium tank. The pump has been in use for a week. To change the helium tank, they had released the clamp holding the adaptor for the disposable tanks and removed the tank and adaptor. They changed the tank and replaced it. The rn stated that she heard a "whooshing" sound, and the pump again alarmed for purge failure when they attempted to turn it back on. This is when they called the hotline. The pump has otherwise been performing as expected. The rn stated that it has been about 5 minutes since the pump was last pumping. The clinical support specialist explained to the rn that the o-ring that seals the connection between the pump and the adaptor had most likely fallen out. The rn told the css that they have not been able to locate anything that looks like the ring that the css described to them. The css recommended that while they are looking for this they should also get another pump ready. The rn stated that they had already sent someone to get another pump. They had not found the o-ring before the other pump arrived, so they moved all connections to the pump that just arrived. It has now been 25 minutes since the pump was last running, and the css explained to the rn, that 30 minutes is the longest you can go without pumping the balloon. The rn verified that it has indeed been about 25 minutes and not more than 30 minutes. They then resumed pumping, and the new pump is now supporting the patient well. The css recommended that they have biomed check out the original pump.

• 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: 6099768
• MDR Text Key: 59782644
• Report Number: 1219856-2016-00246
• 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

• Type of Report: Initial,Followup
• Report Date: 10/16/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: IAP-0500
• Other Device ID Number: 30801902051715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/15/2016
• 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: Unkown