MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AC3 OPTIMUS IABP NA/EMEA; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0700

Device Problems Device Alarm System (1012); Loss of Power (1475); Material Twisted/Bent (2981)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 12/04/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the intra-aortic balloon pump (iabp) has given 5 minute alarm then shuts off.The battery was replaced.The field service engineer was called to service the pump, during service it was noted that kinked tubing caused 7vdc on the balloon pressure waveform (bpw).As a result, the field service engineer replaced the pneumatic control system (pcs).There was no report of patient consequence.

Manufacturer Narrative

(b)(4).Teleflex received the device for investigation.The reported complaint of alarm: system error 1 is confirmed.The pressure sensor on the pcs assembly was noted to be out of range, resulting in the system error 1 alarm.The root cause of how the pressure sensor became out of range is undetermined.A potential cause is a faulty pressure transducer.The pcs assembly was replaced by the fse and the pump was returned to service.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for any developing trends.No further action required at this time.

Event Description

It was reported that the intra-aortic balloon pump (iabp) has given 5 minute alarm then shuts off.The battery was replaced.The field service engineer was called to service the pump, during service it was noted that kinked tubing caused 7vdc on the balloon pressure waveform (bpw).As a result, the field service engineer replaced the pneumatic control system (pcs).There was no report of patient consequence.

• Brand Name: AC3 OPTIMUS IABP NA/EMEA
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8196528
• MDR Text Key: 131490420
• Report Number: 3010532612-2018-00402
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902084965
• UDI-Public: 00801902084965
• Combination Product (y/n): N
• PMA/PMN Number: K162820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0700
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Date Manufacturer Received: 01/31/2019
• Patient Sequence Number: 1