MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. AUTOCAT 2; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAP-0400

Device Problems Moisture Damage (1405); Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was report by the registered nurse that during use on a patient, a heparinized saline bag exploded and the liquid spilled over the machine.This caused the pump loss of the ap waveform and eventually led to the loss of all signals.The pump did not start back up.The pump was off for approximately twenty minutes.The patient remained stable during the time.As a result the pump was switch out and replaced successfully, there was a delay in therapy to switch to another pump which caused no complications to the patient.Patient outcome: meeting goals of therapy at end of call.There were no reports of patient's complications, serious injury or death.

Manufacturer Narrative

(b)(4).Teleflex did not receive the device for investigation.The reported complaint of "ap signal loss and the pump shut off" is confirmed based on the details provided from the customer.The liquid from the saline bag spilled over the pump.The cause of the reported complaint was related to a liquid spill on the pump.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 complaint will be monitored for any developing trends.No further action required at this time.

Event Description

It was report by the registered nurse that during use on a patient, a heparinized saline bag exploded and the liquid spilled over the machine.This caused the pump loss of the ap waveform and eventually led to the loss of all signals.The pump did not start back up.The pump was off for approximately twenty minutes.The patient remained stable during the time.As a result the pump was switch out and replaced successfully, there was a delay in therapy to switch to another pump which caused no complications to the patient.Patient outcome: meeting goals of therapy at end of call.There were no reports of patient's complications, serious injury or death.

• Brand Name: AUTOCAT 2
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 7314297
• MDR Text Key: 101662204
• Report Number: 3010532612-2018-00033
• 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: 02/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAP-0400
• Other Device ID Number: 00801902051721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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