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

Catalog Number IAP-0500

Device Problems Unable to Obtain Readings (1516); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the rn called the clinical support specialist to troubleshoot a "light weight sensor (lws)".The fiber optic sensor (fos) waveform has been a flat line during all of the troubleshooting attempts.The rn was not able to switch the pump at the time of the call and therefore the central lumen was flushed and utilized.The waveform is much better and the patient support looks "great.A second call was received the following day with the same patient and same pump.The second rn called to troubleshoot "low augmentation".The css discussed with the rn the multiple factors with augmentation.During discussion, the css suggested connecting the fos to another console.The rn was able to connect the fos to a second pump.The rn received a waveform as expected and they were able to calibrate the fiber optic sensor and the icon is white.The patient continued to receive therapy.There was no reported death or complications to the patient.A delay in therapy while exchanging the pump but no harm to the patient was caused.Patient outcome: the patient remained stable.

Manufacturer Narrative

Qn# (b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of "fos not recognized" is not able to be confirmed.The pump was checked by the hospital biomed and the problem could not be reproduced.The root cause of the reported 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.This complaint will be monitored for any developing trends.

Event Description

It was reported that the rn called the clinical support specialist to troubleshoot a "light weight sensor (lws)".The fiber optic sensor (fos) waveform has been a flat line during all of the troubleshooting attempts.The rn was not able to switch the pump at the time of the call and therefore the central lumen was flushed and utilized.The waveform is much better and the patient support looks "great.A second call was received the following day with the same patient and same pump.The second rn called to troubleshoot "low augmentation".The css discussed with the rn the multiple factors with augmentation.During discussion, the css suggested connecting the fos to another console.The rn was able to connect the fos to a second pump.The rn received a waveform as expected and they were able to calibrate the fiber optic sensor and the icon is white.The patient continued to receive therapy.There was no reported death or complications to the patient.A delay in therapy while exchanging the pump but no harm to the patient was caused.Patient outcome: the patient remained stable.

• Brand Name: AUTOCAT2 WAVE
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 9 plymouth street; everett MA 02149
• Manufacturer Contact: carmen sherman ; 16 elizabeth drive; chelmsford, MA 01824 ; 9782505100
• MDR Report Key: 6731849
• MDR Text Key: 80816004
• Report Number: 1219856-2017-00155
• 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: 06/26/2017

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
• Other Device ID Number: 00801902051714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2017
• Initial Date FDA Received: 07/21/2017
• Supplement Dates Manufacturer Received: 08/23/2017
• Supplement Dates FDA Received: 08/23/2017
• 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