MAUDE Adverse Event Report: CIRCULATORY TECHNOLOGY INC BIGGER BETTER BLADDER; RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Model Number	BBB38
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user states that the bigger better-bladder failed due to a leaking pigtail the unit was not returned for inspection and confirmation.This is the first and only complaint received for a leaking pigtail since implementation of a corrective action on 10/6/2017.Each unit is tested during the manufacturing process and no issues were reported.A review of the ohr found no evidence of nonconformities with no reported defects.Since implementation of the corrective action on 10/6/17, this is the only report of a leaking pigtail.Specifically, (b)(4) lots of better-bladders and bigger better-bladders have been manufactured with this complaint resulting in a defect rate of (b)(4).The leaking pigtail could not be confirmed and hence may have been caused by other factors.For example, the leak may have been due to a poor connection anywhere between the pigtail and the pressure transducer (e.G.Numerous stopcocks and numerous luer fittings) and not a leaking pigtail.Note the udi # is (b)(4).
Event or Problem Description
From medwatch report (b)(4): the bigger better bladder in the ecmo circuit has an air chamber on the outside for equilibrating the pressure during the run that ensures appropriate negative pressure on the system.During the previous night, specialist has trouble maintaining in the air chamber to the right pressure.They found the air chamber pigtail was leaking requiring the blabber to be changed on the circuit.The patient was off bypass for 1:20 (one minute 20 seconds) during the change, but tolerated the brief time without incident.Possibly a manufacturer defect.Event was related to a defective consumable which was replaced with no event.Machine did not malfunction-no further action by biomed.

• Brand Name: BIGGER BETTER BLADDER
• Common Device Name: RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CIRCULATORY TECHNOLOGY INC; 21 singworth st.; oyster bay NY 11771
• MDR Report Key: 9354816
• Report Number: 1000522036-2019-00001
• Device Sequence Number: 18966554
• Product Code: DTN
• UDI-Device Identifier: 00851997007011
• UDI-Public: (01)00851997007011(10)S19955(17)201113(11)171113
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K98124
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: BBB38
• Device Catalogue Number: BBB38
• Device Lot Number: 5300-S19955
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1
• Patient Age: 23 YR