MAUDE Adverse Event Report: DATASCOPE FAIRFIELD ECC SMALL - RESPIRATORY BEQ-TOP 5210 CARDIOPULMONARY TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Catalog Number 701055604R01

Device Problems Disconnection (1171); Moisture Damage (1405); Device Operates Differently Than Expected (2913); Device Packaging Compromised (2916)

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

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and could not be evaluated.It was discarded by the user.We are unable to confirm the reported event.If new information becomes available, a supplemental report will be submitted.(b)(4).

Event Description

It was reported that a better bladder component used with ecc small-respiratory cardiopulmonary tubing pack failed.The better bladder (original) was part of a field action initiated by the vendor, and was pull tested per instructions supplied by the vendor; the better bladder failed testing prior to patient use and was discarded.The original better bladder was replaced with another better bladder (first replacement) which was supplied by the vendor as part of the field action.The first replacement better bladder failed on (b)(6) 2017.After passing testing on wet circuit it failed after less than 24 hours on patient.First replacement better bladder replaced with a new better bladder (second replacement) which was supplied by the vendor per the ongoing field action.The patient was on bypass with jump bridge; patient did not have to come off extracorporeal membrane oxygenation (ecmo).Second replacement better bladder failed on (b)(6) 2017.Bone wax was applied at site of pressure port connection to housing and was able to continue to be used.The second replacement better bladder was still in use but was reported to be available for return after the patient came off of ecmo.All the involved devices were discarded by the facility.There was no reported injury to the patient.This report is for the first replacement better bladder (from lot number 5290-s19872) supplied with the tubing pack.Only one datascope (b)(4) ecc small-respiratory cardiopulmonary tubing pack was involved in all three events; there was no allegation against the datascope (b)(4) tubing pack.Report 2 of 3.

Manufacturer Narrative

Initial mdr section g.5 pma/510(k)# changed from : k08059223 to: k080592.Complaint # (b)(4).

Event Description

It was reported that a better bladder component used with ecc small-respiratory cardiopulmonary tubing pack failed.The better bladder (original) was part of a field action initiated by the vendor, and was pull tested per instructions supplied by the vendor; the better bladder failed testing prior to patient use and was discarded.The original better bladder was replaced with another better bladder (first replacement) which was supplied by the vendor as part of the field action.The first replacement better bladder failed on (b)(6) 2017.After passing testing on wet circuit it failed after less than 24 hours on patient.First replacement better bladder replaced with a new better bladder (second replacement) which was supplied by the vendor per the ongoing field action.The patient was on bypass with jump bridge; patient did not have to come off extracorporeal membrane oxygenation (ecmo).Second replacement better bladder failed on (b)(6) 2017.Bone wax was applied at site of pressure port connection to housing and was able to continue to be used.The second replacement better bladder was still in use but was reported to be available for return after the patient came off of ecmo.All the involved devices were discarded by the facility.There was no reported injury to the patient.This report is for the first replacement better bladder (from lot number 5290-s19872) supplied with the tubing pack.Only one datascope fairfield ecc small-respiratory cardiopulmonary tubing pack was involved in all three events; there was no allegation against the datascope fairfield tubing pack.Report 2 of 3.

• Brand Name: ECC SMALL - RESPIRATORY BEQ-TOP 5210 CARDIOPULMONARY TUBING PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DATASCOPE FAIRFIELD; 15 law drive; fairfield NJ 07004
• MDR Report Key: 7174291
• MDR Text Key: 96939938
• Report Number: 2248146-2018-00014
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• 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: 02/27/2020

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: No Information
• Device Expiration Date: 08/11/2019
• Device Catalogue Number: 701055604R01
• Device Lot Number: 3000056130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/12/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 02/26/2020
• Supplement Dates FDA Received: 02/27/2020
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3