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

Catalog Number IAP-0500

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).For related complaint see mdr #3010532612-2019-00225 and tc # (b)(4).

Event Description

It was reported by the rn that blood was noted in the helium driveline tubing.Initially the doctor refused to remove the intra-aortic balloon (iab), as the intra-aortic balloon pump (iabp) was "not alarming" and the patient was still augmenting.No alarms were reported.As a result, the iab was removed.The patient was stable with no difficulty of iab removal.There was no report of patient complication or serious injury and death.

Event Description

It was reported by the rn that blood was noted in the helium driveline tubing.Initially the doctor refused to remove the intra-aortic balloon (iab), as the intra-aortic balloon pump (iabp) was "not alarming" and the patient was still augmenting.No alarms were reported.As a result, the iab was removed.The patient was stable with no difficulty of iab removal.There was no report of patient complication or serious injury and death.

Manufacturer Narrative

(b)(4).For related complaint see mdr #3010532612-2019-00225 and tc #1900070125.Teleflex did not receive the device for investigation therefore the reported complaint of iabp did not alarm during iab catheter leak is not able to be confirmed.Additional information indicates blood entered the pump and all parts in contact with blood were replaced.The pump passed functional check with no abnormalities.The root cause of the complaint is undetermined.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.The reported complaint will be monitored for any developing trends.No further action required at this time.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8799522
• MDR Text Key: 151340824
• Report Number: 3010532612-2019-00224
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• PMA/PMN Number: K060309
• 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: 06/26/2019

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1